78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04867317 (ClinicalTrials.gov) | March 1, 2022 | 8/4/2021 | AGH Replacement Therapy With mTBI | CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency;Mild Traumatic Brain Injury | Drug: Somatropin;Other: Placebo | VA Office of Research and Development | NULL | Not yet recruiting | 21 Years | 55 Years | All | 172 | Phase 3 | United States |
| 2 | EUCTR2020-000929-42-BG (EUCTR) | 07/01/2022 | 20/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 3 | JPRN-jRCT2031210366 | 15/11/2021 | 05/10/2021 | An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | Growth hormone deficiency in children | [Investigational product] JR-142 0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection [Comparatar product] INN: Somatropin 0.175 mg/kg/week, daily subcutaneous injection | Ioroi Minoru | NULL | Not Recruiting | Not applicable | Not applicable | Both | 24 | Phase 2 | Japan |
| 4 | EUCTR2020-000929-42-IT (EUCTR) | 18/10/2021 | 08/06/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: [ACP-011] INN or Proposed INN: lonapegsomatropin Product Name: lonapegsomatropin drug product Product Code: [ACP-011] INN or Proposed INN: lonapegsomatropin Product Name: Norditropin FlexPro 5mg/1.5 ml Product Code: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 5 | EUCTR2020-000929-42-DK (EUCTR) | 05/08/2021 | 12/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 6 | EUCTR2020-000929-42-DE (EUCTR) | 09/06/2021 | 14/10/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Japan;New Zealand;Germany;Bulgaria;Georgia;Romania;Poland;Canada;Armenia;United Kingdom;Turkey;Netherlands;Denmark;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia | ||
| 7 | JPRN-jRCT2051200129 | 02/06/2021 | 02/02/2021 | A trial to compare once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | A multicenter, randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) | -Drug: Lonapegsomatropin Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose. -Other: Placebo The placebo for lonapegsonatropin drug product will contain the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution will be administered by SC injection via syringe and needle. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo will receive the same dose volume as if they would have been randomized to once-weekly lonapegsomatropin. -Drug: Somatropin Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose. | Beckert Michael | NULL | Recruiting | >= 23age old | <= 80age old | Both | 240 | Phase 3 | Australia;Belarus;Bulgaria;Canada;Denmark;France;Georgia;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Poland;Romania;Russia;Serbia;Slovakia;Spain;Turkey;UK;Ukraine;USA;Armenia;Japan |
| 8 | EUCTR2020-000929-42-ES (EUCTR) | 21/04/2021 | 01/02/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 9 | EUCTR2020-000929-42-SK (EUCTR) | 12/04/2021 | 24/11/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 10 | EUCTR2020-000929-42-GR (EUCTR) | 23/03/2021 | 04/03/2021 | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Belarus;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 11 | JPRN-jRCT2031200372 | 01/03/2021 | 19/02/2021 | Phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | Phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | Growth hormone deficiency in children | [Investigational product] JR-142 0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection [Comparatar product] INN: Somatropin 0.175 mg/kg/week, daily subcutaneous injection | Ioroi Minoru | NULL | Recruiting | >= 3age old | < 10age old | Both | 24 | Phase 2 | Japan |
| 12 | NCT04615273 (ClinicalTrials.gov) | December 3, 2020 | 29/10/2020 | A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency | foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency;Endocrine System Diseases;Hormone Deficiency | Drug: Lonapegsomatropin;Other: Placebo;Drug: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Recruiting | 23 Years | 80 Years | All | 240 | Phase 3 | United States;Armenia;Australia;Canada;Georgia;Greece;Japan;Poland;Slovakia;Turkey;Ukraine |
| 13 | EUCTR2018-000231-27-ES (EUCTR) | 21/04/2020 | 28/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 14 | EUCTR2018-000231-27-PL (EUCTR) | 23/03/2020 | 04/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Germany;Norway;Japan;United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland | ||
| 15 | EUCTR2018-000231-27-HU (EUCTR) | 23/03/2020 | 05/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | ||
| 16 | EUCTR2018-000231-27-LV (EUCTR) | 05/03/2020 | 15/01/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Germany;Latvia;Norway;Algeria;Japan;Korea, Republic of | ||
| 17 | EUCTR2018-000231-27-EE (EUCTR) | 17/02/2020 | 14/01/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 18 | NCT04020913 (ClinicalTrials.gov) | July 22, 2019 | 24/5/2019 | Skeletal Muscle Effects of GH in Boys | Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency | Growth Hormone Deficiency;Idiopathic Short Stature | Drug: Somatropin injection | Nemours Children's Clinic | Novo Nordisk A/S | Recruiting | 6 Years | 11 Years | Male | 45 | United States | |
| 19 | EUCTR2018-000231-27-SI (EUCTR) | 17/07/2019 | 14/06/2019 | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Japan | ||
| 20 | EUCTR2018-000918-38-BG (EUCTR) | 16/07/2019 | 23/05/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 21 | EUCTR2018-000918-38-SK (EUCTR) | 11/07/2019 | 11/02/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 22 | EUCTR2018-000918-38-CZ (EUCTR) | 27/06/2019 | 20/03/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 23 | EUCTR2018-000231-27-GB (EUCTR) | 30/05/2019 | 03/09/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Latvia;Norway;Germany;Algeria;Japan;Korea, Republic of | ||
| 24 | EUCTR2018-000231-27-AT (EUCTR) | 22/05/2019 | 02/04/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 25 | EUCTR2018-000918-38-GB (EUCTR) | 16/05/2019 | 27/11/2018 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 26 | EUCTR2018-000231-27-DK (EUCTR) | 15/05/2019 | 28/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Algeria;Japan | ||
| 27 | EUCTR2018-000231-27-DE (EUCTR) | 23/04/2019 | 11/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 28 | EUCTR2018-000231-27-IT (EUCTR) | 19/04/2019 | 30/07/2021 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 Product Code: [NN8640] INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290S Product Code: [NN8640] INN or Proposed INN: Somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 Product Code: [NN8640] INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml Product Name: Norditropin FlexPro 10 mg/1.5 ml Product Code: [N/A] INN or Proposed INN: somatropin Other descriptive name: somatropin | NOVO NORDISK. S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;Canada;Poland;Germany;Norway;Algeria;Japan | ||
| 29 | NCT04513171 (ClinicalTrials.gov) | December 26, 2018 | 7/8/2020 | Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children | A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency. | Growth Hormone Deficiency | Drug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: Norditropin | Xiamen Amoytop Biotech Co., Ltd. | Tongji Hospital | Recruiting | 3 Years | 11 Years | All | 400 | Phase 2/Phase 3 | China |
| 30 | ChiCTR1800017144 | 2018-07-25 | 2018-07-13 | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | Growth hormone deficiency | Two groups:low dose versus high dose of Pegylated Somatropin; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 3 | 14 | Both | Two groups:900; | China‘ | |
| 31 | EUCTR2016-001145-11-DE (EUCTR) | 12/02/2018 | 14/12/2016 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine | ||
| 32 | JPRN-JapicCTI-183963 | 25/12/2017 | 17/05/2018 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY | Treatment of children with growth failure due to growth hormone deficiency (GHD) | Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day). | OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd) | NULL | complete | 3 | 11 | BOTH | 44 | Phase 3 | Japan |
| 33 | EUCTR2016-003874-42-GR (EUCTR) | 20/12/2017 | 21/11/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand | ||
| 34 | EUCTR2016-003874-42-GB (EUCTR) | 04/09/2017 | 03/01/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus | ||
| 35 | EUCTR2016-003874-42-DE (EUCTR) | 04/08/2017 | 01/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 36 | EUCTR2016-003874-42-IT (EUCTR) | 16/06/2017 | 06/09/2021 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin | PRM|21097 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;Greece;Spain;Poland;Bulgaria;Germany;United Kingdom;Italy | ||
| 37 | EUCTR2016-003874-42-ES (EUCTR) | 18/05/2017 | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 38 | EUCTR2016-003874-42-BG (EUCTR) | 26/04/2017 | 13/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | ||
| 39 | EUCTR2016-001145-11-IT (EUCTR) | 07/04/2017 | 10/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH CT-301 (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: Sterile Water for Injection | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 40 | NCT03104010 (ClinicalTrials.gov) | April 2017 | 28/3/2017 | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: Somatropin Injection | GeneScience Pharmaceuticals Co., Ltd. | Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China Hospital | Recruiting | 18 Years | 60 Years | All | 180 | Phase 2 | China |
| 41 | EUCTR2016-001145-11-PL (EUCTR) | 31/03/2017 | 17/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 42 | EUCTR2016-001145-11-GR (EUCTR) | 28/03/2017 | 02/02/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 43 | NCT03290235 (ClinicalTrials.gov) | March 1, 2017 | 19/9/2017 | Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | Growth Retardation | Drug: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 42 Months | 15 Years | All | 1500 | Phase 4 | China |
| 44 | NCT02968004 (ClinicalTrials.gov) | December 2016 | 13/11/2016 | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Active, not recruiting | 3 Years | 11 Years | All | 224 | Phase 3 | United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey |
| 45 | EUCTR2015-001939-21-LV (EUCTR) | 15/08/2016 | 31/05/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 46 | NCT03015909 (ClinicalTrials.gov) | August 11, 2016 | 10/11/2016 | Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. | A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable Device | Short Stature, Idiopathic;Infant, Small for Gestational Age;Growth Hormone Deficiency;Chronic Renal Failure;Turner Syndrome | Drug: Somatropin | LG Life Sciences | NULL | Completed | 4 Years | 15 Years | All | 116 | Phase 4 | Korea, Republic of |
| 47 | EUCTR2015-001939-21-LT (EUCTR) | 04/05/2016 | 29/02/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 48 | EUCTR2015-001939-21-PL (EUCTR) | 19/04/2016 | 18/01/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of | ||
| 49 | EUCTR2015-001939-21-EE (EUCTR) | 30/03/2016 | 16/02/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 50 | EUCTR2015-000531-32-DE (EUCTR) | 14/03/2016 | 20/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 51 | EUCTR2015-000531-32-BE (EUCTR) | 17/02/2016 | 30/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden | ||
| 52 | EUCTR2015-000531-32-SE (EUCTR) | 14/01/2016 | 04/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 53 | EUCTR2014-002736-13-PL (EUCTR) | 08/01/2016 | 29/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 54 | EUCTR2015-000531-32-SI (EUCTR) | 15/12/2015 | 11/11/2015 | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 55 | EUCTR2015-000531-32-AT (EUCTR) | 10/12/2015 | 03/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 56 | EUCTR2014-002736-13-HR (EUCTR) | 09/12/2015 | 01/02/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 57 | EUCTR2015-001939-21-GR (EUCTR) | 12/11/2015 | 13/10/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia | ||
| 58 | EUCTR2015-001939-21-SK (EUCTR) | 22/10/2015 | 27/07/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia | ||
| 59 | EUCTR2014-002736-13-SI (EUCTR) | 15/10/2015 | 12/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 60 | EUCTR2015-001939-21-CZ (EUCTR) | 14/10/2015 | 10/07/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia | ||
| 61 | EUCTR2005-000384-26-FR (EUCTR) | 12/10/2015 | 04/10/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 62 | EUCTR2013-002892-16-LV (EUCTR) | 12/10/2015 | 31/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden | ||
| 63 | EUCTR2014-002736-13-CZ (EUCTR) | 01/10/2015 | 10/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 64 | EUCTR2013-002892-16-LT (EUCTR) | 30/09/2015 | 27/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 65 | EUCTR2014-002736-13-IT (EUCTR) | 25/08/2015 | 27/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 66 | EUCTR2014-002736-13-LT (EUCTR) | 20/08/2015 | 14/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 67 | EUCTR2014-002736-13-DE (EUCTR) | 19/08/2015 | 13/03/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 68 | EUCTR2014-002736-13-ES (EUCTR) | 24/07/2015 | 08/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 69 | EUCTR2015-001939-21-HU (EUCTR) | 16/07/2015 | 22/05/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 70 | EUCTR2014-002698-13-PL (EUCTR) | 30/06/2015 | 22/05/2015 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 71 | EUCTR2014-002736-13-HU (EUCTR) | 26/06/2015 | 10/04/2015 | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 72 | EUCTR2014-002736-13-GR (EUCTR) | 26/06/2015 | 10/06/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden;Lithuania;Austria;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey | ||
| 73 | EUCTR2014-002736-13-AT (EUCTR) | 22/06/2015 | 04/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 74 | EUCTR2014-002698-13-DE (EUCTR) | 11/06/2015 | 23/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 75 | EUCTR2013-004468-69-PL (EUCTR) | 28/05/2015 | 05/02/2015 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 76 | EUCTR2014-002736-13-SE (EUCTR) | 25/05/2015 | 21/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 77 | EUCTR2014-002736-13-SK (EUCTR) | 20/05/2015 | 15/01/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 78 | NCT02311894 (ClinicalTrials.gov) | March 31, 2015 | 4/12/2014 | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency | A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY) | Growth Hormone Deficiency | Drug: Somatropin | Genentech, Inc. | NULL | Completed | 3 Years | 14 Years | All | 82 | Phase 4 | United States |
| 79 | EUCTR2014-002698-13-GR (EUCTR) | 26/02/2015 | 17/03/2015 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 80 | EUCTR2013-004468-69-BG (EUCTR) | 18/02/2015 | 07/10/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 81 | EUCTR2014-002698-13-HU (EUCTR) | 17/02/2015 | 15/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 82 | NCT02382939 (ClinicalTrials.gov) | February 12, 2015 | 10/2/2015 | A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency;Growth Hormone Disorder | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 92 | Phase 3 | Denmark;France;Germany;Japan;Sweden;United Kingdom |
| 83 | EUCTR2014-002698-13-SE (EUCTR) | 03/02/2015 | 18/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 84 | EUCTR2014-000290-39-GB (EUCTR) | 30/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | European Union;Denmark;Japan;United Kingdom;Sweden | ||
| 85 | EUCTR2013-004468-69-ES (EUCTR) | 22/01/2015 | 03/11/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 86 | EUCTR2014-000290-39-DK (EUCTR) | 22/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Sweden;Japan;United Kingdom;Denmark;European Union | |||
| 87 | EUCTR2014-002698-13-SK (EUCTR) | 14/01/2015 | 09/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 88 | NCT03249480 (ClinicalTrials.gov) | January 2015 | 24/7/2017 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 89 | NCT02976675 (ClinicalTrials.gov) | January 2015 | 24/11/2016 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong University | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China |
| 90 | EUCTR2013-002892-16-DE (EUCTR) | 22/12/2014 | 29/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 91 | NCT02380235 (ClinicalTrials.gov) | December 2014 | 2/3/2015 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I) | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China | |
| 92 | EUCTR2013-002892-16-GB (EUCTR) | 20/11/2014 | 24/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 93 | EUCTR2014-000290-39-SE (EUCTR) | 07/11/2014 | 07/10/2014 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | |||
| 94 | NCT02908958 (ClinicalTrials.gov) | November 2014 | 19/9/2016 | Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency | Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 95 | NCT02314676 (ClinicalTrials.gov) | November 2014 | 27/11/2014 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Dwarfism, Pituitary | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 3 Years | N/A | Both | 900 | Phase 4 | China | |
| 96 | NCT02229851 (ClinicalTrials.gov) | October 31, 2014 | 26/8/2014 | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 23 Years | 79 Years | All | 301 | Phase 3 | United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom |
| 97 | EUCTR2013-002892-16-SE (EUCTR) | 07/10/2014 | 03/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 98 | EUCTR2013-004468-69-CZ (EUCTR) | 08/08/2014 | 11/04/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 99 | EUCTR2013-004468-69-GR (EUCTR) | 29/07/2014 | 16/06/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 100 | NCT02018172 (ClinicalTrials.gov) | July 2014 | 17/12/2013 | Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device | Growth Hormone Deficiency;Turner's Syndrome | Drug: somatropin | Ferring Pharmaceuticals | NULL | Terminated | N/A | N/A | Both | 3 | N/A | France | |
| 101 | EUCTR2013-004468-69-HU (EUCTR) | 11/06/2014 | 21/02/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia | ||
| 102 | NCT02092077 (ClinicalTrials.gov) | April 30, 2014 | 14/3/2014 | A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth Hormone-Deficiency | Drug: TV-1106;Drug: somatropin | Teva Pharmaceutical Industries, Ltd. | NULL | Terminated | 3 Years | 11 Years | All | 65 | Phase 2 | Belarus;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;Czech Republic;Slovenia |
| 103 | EUCTR2011-001826-61-BG (EUCTR) | 07/02/2014 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 104 | EUCTR2013-000013-20-ES (EUCTR) | 02/01/2014 | 10/01/2014 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 1 | France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Belgium;Spain;Austria;Israel;Norway;Switzerland;Sweden | ||
| 105 | EUCTR2013-000013-20-SE (EUCTR) | 20/12/2013 | 12/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 106 | EUCTR2013-000013-20-BE (EUCTR) | 17/12/2013 | 11/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 107 | EUCTR2013-000013-20-AT (EUCTR) | 16/12/2013 | 11/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 108 | NCT01973244 (ClinicalTrials.gov) | December 16, 2013 | 22/10/2013 | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 13 Years | All | 32 | Phase 1 | Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland |
| 109 | EUCTR2013-000013-20-SI (EUCTR) | 09/12/2013 | 20/09/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 110 | EUCTR2012-002787-27-BG (EUCTR) | 11/09/2013 | 03/06/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany | ||
| 111 | EUCTR2012-004975-37-SE (EUCTR) | 05/09/2013 | 09/07/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden | ||
| 112 | EUCTR2012-004975-37-DE (EUCTR) | 05/08/2013 | 02/05/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 113 | EUCTR2012-002787-27-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 114 | EUCTR2012-004975-37-CZ (EUCTR) | 20/06/2013 | 04/01/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 115 | EUCTR2012-002787-27-DE (EUCTR) | 17/06/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 116 | EUCTR2012-004975-37-SI (EUCTR) | 22/05/2013 | 17/04/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden | ||
| 117 | EUCTR2012-004263-47-CZ (EUCTR) | 13/05/2013 | 05/03/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 118 | EUCTR2012-002787-27-CZ (EUCTR) | 10/05/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 119 | EUCTR2012-004263-47-DE (EUCTR) | 03/04/2013 | 25/02/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 120 | EUCTR2011-004553-60-PL (EUCTR) | 02/04/2013 | 09/02/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 121 | EUCTR2012-004975-37-GR (EUCTR) | 27/03/2013 | 29/03/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden | ||
| 122 | EUCTR2012-002787-27-GR (EUCTR) | 04/03/2013 | 15/02/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 123 | NCT01494779 (ClinicalTrials.gov) | March 2013 | 28/11/2011 | Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A. | GH Deficiency (GHD);Growth Retardation | Drug: Somatropin | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | NULL | Not yet recruiting | 18 Years | 32 Years | Male | 32 | Phase 1 | Brazil | |
| 124 | EUCTR2012-004975-37-SK (EUCTR) | 27/02/2013 | 04/03/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 125 | EUCTR2012-002787-27-HU (EUCTR) | 11/02/2013 | 11/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 126 | EUCTR2012-004975-37-HU (EUCTR) | 21/01/2013 | 23/11/2012 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden | ||
| 127 | NCT01731028 (ClinicalTrials.gov) | January 2013 | 16/11/2012 | Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton® | Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice | Growth Hormone Deficiency | Drug: Somatropin | Ferring Pharmaceuticals | NULL | Withdrawn | 3 Years | 18 Years | Both | 0 | N/A | NULL |
| 128 | EUCTR2011-005377-23-ES (EUCTR) | 18/07/2012 | 21/05/2012 | Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD). | A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD). | Spinal Cord Injury and Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10041558;Term: Spinal cord injury thoracic;System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1;Classification code 10041554;Term: Spinal cord injury cervical;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Trade Name: NUTROPIN Product Name: NutropinAq 10 mg/2 ml (30 UI) INN or Proposed INN: SOMATROPIN | Guillem Cuatrecasas Cambra | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain | ||
| 129 | EUCTR2011-004553-60-BG (EUCTR) | 02/07/2012 | 10/04/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 130 | EUCTR2011-004553-60-CZ (EUCTR) | 10/04/2012 | 06/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 131 | NCT01592500 (ClinicalTrials.gov) | February 2012 | 2/5/2012 | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 56 | Phase 2 | Greece;Hungary;Slovakia |
| 132 | EUCTR2011-001826-61-PL (EUCTR) | 25/01/2012 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 133 | EUCTR2011-004553-60-GR (EUCTR) | 23/01/2012 | 27/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel | |||
| 134 | EUCTR2011-004553-60-SK (EUCTR) | 10/01/2012 | 24/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 135 | EUCTR2011-004553-60-HU (EUCTR) | 10/01/2012 | 03/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 2 | Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation | ||
| 136 | NCT01440686 (ClinicalTrials.gov) | September 2011 | 23/9/2011 | Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers | A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers | Growth Hormone Deficiency | Drug: Somatropin;Drug: Placebo | HanAll BioPharma Co., Ltd. | NULL | Completed | 19 Years | 50 Years | Male | 40 | Phase 1 | Korea, Republic of |
| 137 | EUCTR2011-000460-10-CZ (EUCTR) | 22/08/2011 | 22/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 138 | EUCTR2011-000460-10-ES (EUCTR) | 16/08/2011 | 21/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy power for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 139 | EUCTR2011-000460-10-GB (EUCTR) | 03/08/2011 | 17/05/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | idiopathic growth hormone deficientyTurner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: Saizen 8mg click.easy powder for solution for injection Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom | ||
| 140 | EUCTR2011-001826-61-HU (EUCTR) | 29/07/2011 | 23/05/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 141 | EUCTR2010-020742-10-GB (EUCTR) | 09/05/2011 | 04/11/2010 | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 142 | EUCTR2010-020742-10-ES (EUCTR) | 01/04/2011 | 07/01/2011 | Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica | Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica | Niños pre-puberales con déficit idiopático de hormona de crecimiento MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable INN or Proposed INN: SOMATROPINA Other descriptive name: SOMATROPIN Trade Name: INCRELEX 10 mg/ml, solución inyectable INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES INN or Proposed INN: MECASERMINA Other descriptive name: MECASERMINA Trade Name: INCRELEX 10 mg/ml, solución inyectable INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES INN or Proposed INN: MECASERMINA Other descriptive name: MECASERMINA | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Finland;United Kingdom;Spain;Sweden | |||
| 143 | EUCTR2010-023430-23-GB (EUCTR) | 28/03/2011 | 24/01/2011 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;Czech Republic;United Kingdom | |||
| 144 | EUCTR2010-020742-10-SE (EUCTR) | 23/02/2011 | 19/11/2010 | Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW]. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 145 | EUCTR2010-019374-32-AT (EUCTR) | 15/02/2011 | 29/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Austria will be used in this clinical trial. Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany | ||
| 146 | EUCTR2010-023430-23-CZ (EUCTR) | 09/02/2011 | 25/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;United Kingdom;Czech Republic | |||
| 147 | EUCTR2010-023430-23-HU (EUCTR) | 17/01/2011 | 10/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;United Kingdom;Czech Republic | |||
| 148 | EUCTR2010-020742-10-FI (EUCTR) | 10/01/2011 | 22/11/2010 | Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW]. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 149 | EUCTR2009-017354-12-GB (EUCTR) | 08/11/2010 | 18/06/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Netherlands;Germany;United Kingdom;Sweden | ||
| 150 | NCT01243892 (ClinicalTrials.gov) | November 2010 | 17/11/2010 | A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device | A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin® | Growth Hormone Deficiency | Device: NuSpin;Drug: Somatropin | Genentech, Inc. | NULL | Terminated | 2 Years | 14 Years | All | 18 | Phase 4 | United States |
| 151 | EUCTR2009-017354-12-SE (EUCTR) | 11/10/2010 | 09/04/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Czech Republic;Sweden | |||
| 152 | EUCTR2010-021523-28-DE (EUCTR) | 05/10/2010 | 10/08/2010 | A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 153 | EUCTR2010-021523-28-IT (EUCTR) | 28/09/2010 | 27/12/2010 | A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND | A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND | Growth Hormone Deficiency MedDRA version: 9.1;Level: PT;Classification code 10056438 | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: OMNITROPE INN or Proposed INN: Somatropin | ASCENDIS PHARMA A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Germany;Denmark;Italy;Austria;Sweden | ||
| 154 | EUCTR2010-021523-28-SE (EUCTR) | 27/09/2010 | 06/08/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 155 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 156 | EUCTR2010-021523-28-DK (EUCTR) | 13/09/2010 | 29/07/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Austria;Denmark;Germany;Italy;Sweden | ||
| 157 | EUCTR2010-019374-32-SI (EUCTR) | 13/09/2010 | 04/06/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Omnitrop Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: ecombinanat DNA-derived human growth h | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 158 | EUCTR2010-019374-32-CZ (EUCTR) | 06/09/2010 | 15/06/2010 | A study with MOD-4023 in patients with lack of Growth Hormone in the body | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Prolor Biotech Ltd | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel | ||
| 159 | EUCTR2010-021523-28-AT (EUCTR) | 02/09/2010 | 20/07/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 160 | EUCTR2009-017354-12-DE (EUCTR) | 29/07/2010 | 08/06/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Czech Republic;Germany;Sweden | |||
| 161 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 162 | EUCTR2009-017354-12-CZ (EUCTR) | 22/06/2010 | 14/04/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Czech Republic;Sweden | |||
| 163 | EUCTR2009-017354-12-SK (EUCTR) | 09/06/2010 | 26/05/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Trade Name: Genotropin 5.3 mg in injection system Genotropin pen INN or Proposed INN: SOMATROPIN Other descriptive name: n/a Trade Name: Genotropin 12 mg INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Czech Republic;Slovakia;Germany;United Kingdom;Sweden | ||
| 164 | NCT01613573 (ClinicalTrials.gov) | March 2010 | 1/6/2012 | Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children | A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children | Growth Hormone Deficiency | Drug: somatropin AQ;Drug: pegylated somatropin | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology | Completed | 4 Years | 10 Years | Male | 12 | Phase 1 | NULL |
| 165 | EUCTR2008-008240-25-ES (EUCTR) | 04/11/2009 | 10/08/2009 | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Déficit de hormona de crecimientogrowth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Slovenia;Belgium;Spain;Denmark;United Kingdom | ||
| 166 | EUCTR2008-008240-25-DK (EUCTR) | 12/10/2009 | 17/08/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Slovenia;Denmark;France;Spain | |||
| 167 | EUCTR2008-008240-25-GB (EUCTR) | 01/10/2009 | 18/06/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 168 | NCT01109017 (ClinicalTrials.gov) | October 2009 | 19/4/2010 | Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency | A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 387 | N/A | Japan |
| 169 | EUCTR2008-008240-25-FR (EUCTR) | 02/09/2009 | 10/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | ||
| 170 | EUCTR2009-010918-30-IE (EUCTR) | 11/08/2009 | 11/03/2009 | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care. MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign | Trade Name: Genotropin 5.3mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin 12mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.4mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.6mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.8mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.0mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniqu | Amar Agha, Beaumont Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Ireland | |||
| 171 | NCT00936403 (ClinicalTrials.gov) | August 2009 | 9/7/2009 | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone | A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: NNC126-0083;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 12 Years | All | 31 | Phase 2 | Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom |
| 172 | EUCTR2008-004849-28-HU (EUCTR) | 09/07/2009 | 03/06/2009 | A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatment of children with idiopathic growth hormone deficiency - | Idiopathic growth hormone deficiency. MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Zomacton 10 mg/ml INN or Proposed INN: Somatropin Trade Name: Genotropin 12 mg/ml INN or Proposed INN: Somatropin | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 138 | Hungary | ||||
| 173 | NCT00934063 (ClinicalTrials.gov) | July 2009 | 2/7/2009 | An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® | A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin) | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Other: No treatment given | Novo Nordisk A/S | NULL | Completed | 18 Years | N/A | Both | 121 | N/A | Germany |
| 174 | EUCTR2008-008240-25-BE (EUCTR) | 10/06/2009 | 24/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | |||
| 175 | EUCTR2008-008240-25-SI (EUCTR) | 25/05/2009 | 06/05/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 176 | NCT00837863 (ClinicalTrials.gov) | March 2009 | 2/2/2009 | Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency | A Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin | Altus Pharmaceuticals | NULL | Recruiting | 3 Years | 13 Years | Both | 36 | Phase 2 | United States |
| 177 | NCT00630487 (ClinicalTrials.gov) | May 2008 | 28/2/2008 | Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency | Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study) | Growth Hormone Deficiency | Drug: Placebo;Drug: Somatropin | Pfizer | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 3 | Germany |
| 178 | EUCTR2007-000790-36-DE (EUCTR) | 08/01/2008 | 12/12/2007 | Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study | Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study | Isolated Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin 5 mg/ml INN or Proposed INN: Somatropin Trade Name: Genotropin 5 mg/ml INN or Proposed INN: Somatropin | Pfizer Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 179 | EUCTR2007-003586-41-ES (EUCTR) | 26/11/2007 | 20/11/2007 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/A | Tratamiento del déficit de hormona de crecimiento en adultos después de un traumatismo cerebral. MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para solución inyectable (Marca internacional Genotropin) Product Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para sol. inyectable (Marca internacional Genotropin) INN or Proposed INN: Somatropina | Pfizer, S.A | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;Spain;Netherlands;Italy;United Kingdom;Sweden | ||
| 180 | NCT01306357 (ClinicalTrials.gov) | September 2007 | 28/2/2011 | Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device | Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective | Turner's Syndrome;Human Growth Hormone Deficiency | Drug: Somatropin | Ferring Pharmaceuticals | NULL | Completed | N/A | N/A | Both | 87 | N/A | France |
| 181 | EUCTR2006-002278-24-SE (EUCTR) | 15/05/2007 | 05/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 182 | EUCTR2006-002278-24-GB (EUCTR) | 02/05/2007 | 23/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 183 | EUCTR2006-002278-24-SK (EUCTR) | 20/04/2007 | 22/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 184 | EUCTR2006-002278-24-FR (EUCTR) | 13/04/2007 | 24/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 185 | NCT00432263 (ClinicalTrials.gov) | April 2007 | 5/2/2007 | Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury. | Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury | Brain Injuries | Drug: Genotropin (PN-180,307) Somatropin | Pfizer | NULL | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 4 | NULL |
| 186 | NCT00455260 (ClinicalTrials.gov) | April 2007 | 2/4/2007 | A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: hGH-ViaDerm™ System (hGH or somatropin);Device: hGH-ViaDerm™ System | Teva Neuroscience, Inc. | Teva Pharmaceutical Industries;TransPharma Medical | Completed | 20 Years | 60 Years | Both | 60 | Phase 1 | Israel;Ukraine |
| 187 | NCT01495468 (ClinicalTrials.gov) | March 2007 | 16/12/2011 | Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical Trial | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin University | Completed | 8 Years | 15 Years | All | 343 | Phase 3 | China |
| 188 | NCT00601419 (ClinicalTrials.gov) | March 2007 | 15/1/2008 | Drug Use Investigation of Somatropin for GHD-ADULTS. | Drug Use Investigation of GENOTROPIN for GHD-ADULTS. | Dwarfism, Growth Hormone Deficiency | Drug: Somatropin | Pfizer | NULL | Completed | N/A | N/A | All | 230 | N/A | NULL |
| 189 | EUCTR2006-002278-24-AT (EUCTR) | 05/01/2007 | 10/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 190 | EUCTR2005-000346-36-LT (EUCTR) | 29/12/2006 | 24/10/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania | ||
| 191 | EUCTR2006-002278-24-CZ (EUCTR) | 14/12/2006 | 08/09/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | ||
| 192 | EUCTR2006-002278-24-ES (EUCTR) | 13/12/2006 | 10/03/2010 | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 193 | EUCTR2006-002278-24-DE (EUCTR) | 06/10/2006 | 15/08/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 194 | NCT01342146 (ClinicalTrials.gov) | May 2006 | 21/4/2011 | Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children | Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study | Growth Hormone Deficiency | Drug: pegylated Somatropin;Drug: Jintropin AQ | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University | Completed | N/A | N/A | All | 101 | Phase 2 | NULL |
| 195 | NCT00960128 (ClinicalTrials.gov) | April 1, 2006 | 13/8/2009 | Observational Prospective Study on Patients Treated With Norditropin® | NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin® | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 21249 | N/A | Argentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro |
| 196 | EUCTR2005-000384-26-IT (EUCTR) | 23/03/2006 | 02/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency | Growth hormone deficiency in adult MedDRA version: 6.1;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: Somatropin | BIOPARTNERS GMBH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Italy;Sweden | |||
| 197 | EUCTR2005-004478-26-SE (EUCTR) | 13/01/2006 | 28/10/2005 | Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. | Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. | Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours. | Trade Name: Norditropin SimpleXx Product Name: Norditropin SimpleXx INN or Proposed INN: somatropin | Karolinska universitetssjukhuset | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 198 | EUCTR2005-000384-26-DE (EUCTR) | 20/12/2005 | 02/06/2006 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;Spain;Sweden | ||
| 199 | EUCTR2005-000384-26-AT (EUCTR) | 10/11/2005 | 10/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | BioPartners | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 200 | EUCTR2005-000384-26-SK (EUCTR) | 27/10/2005 | 19/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 201 | EUCTR2005-000384-26-GB (EUCTR) | 21/10/2005 | 17/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 202 | EUCTR2005-000384-26-CZ (EUCTR) | 30/09/2005 | 08/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 203 | EUCTR2005-000346-36-FI (EUCTR) | 22/09/2005 | 30/05/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 204 | EUCTR2005-000384-26-SE (EUCTR) | 13/09/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 205 | NCT00271518 (ClinicalTrials.gov) | September 2005 | 29/12/2005 | Treatment of Children With Insufficient Secretion of Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone | Growth Hormone Deficiency (GHD) | Drug: growth hormone (somatropin) | LG Life Sciences | BioPartners GmbH | Active, not recruiting | 3 Years | 11 Years | Both | 144 | Phase 3 | United States |
| 206 | EUCTR2005-000384-26-ES (EUCTR) | 22/08/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 138 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 207 | EUCTR2005-000346-36-SE (EUCTR) | 18/08/2005 | 16/06/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 208 | EUCTR2005-000346-36-DE (EUCTR) | 16/08/2005 | 06/06/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 209 | NCT01604161 (ClinicalTrials.gov) | May 2005 | 21/5/2012 | Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome | A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs. | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 2016 | N/A | Japan |
| 210 | EUCTR2004-000356-17-DK (EUCTR) | 19/04/2005 | 29/11/2004 | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction. MedDRA version: 7.0;Classification code 10056438 | Trade Name: NutropinAq Product Name: NutropinAq INN or Proposed INN: Somatropin Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli | Beaufour Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Finland;Denmark;Italy | ||
| 211 | EUCTR2004-000356-17-AT (EUCTR) | 12/03/2005 | 02/05/2005 | Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima | Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima | Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq(tm) is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction. | Trade Name: NutropinAq Product Name: NutropinAq INN or Proposed INN: Somatropin | Beaufour Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Finland;Denmark;Austria;Italy | ||
| 212 | EUCTR2004-004835-72-GB (EUCTR) | 12/01/2005 | 17/02/2005 | A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) | A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) | Growth hormone deficiency in adult life | Trade Name: Norditropin SimpleXx 5mg/1.5ml Product Name: Norditropin SimpleXx 5mg/1.5ml INN or Proposed INN: Somatropin Other descriptive name: Growth Hormone, GH | University of Birmingham | University Hospital Birmingham Foundation NHS Trust | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom | |||
| 213 | NCT00163189 (ClinicalTrials.gov) | January 2005 | 9/9/2005 | Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm | Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm | Growth Hormone Deficiency | Drug: Somatropin | Pfizer | NULL | Completed | N/A | N/A | All | 98 | Phase 3 | France |
| 214 | NCT00184730 (ClinicalTrials.gov) | November 2004 | 13/9/2005 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA. | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 19 Years | 67 Years | Both | 86 | Phase 3 | Japan |
| 215 | NCT00191165 (ClinicalTrials.gov) | March 2004 | 12/9/2005 | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | NULL | Completed | N/A | 14 Years | All | 27 | Phase 3 | Italy |
| 216 | NCT00080483 (ClinicalTrials.gov) | March 2004 | 5/4/2004 | Testosterone and Growth Hormone for Bone Loss in Men | Will Testosterone and Growth Hormone Improve Bone Structure? | Hypopituitarism;Hypogonadism;Growth Hormone Deficiency | Drug: Testosterone plus somatropin;Drug: testosterone | University of Pennsylvania | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 18 Years | N/A | Male | 35 | Phase 2 | United States |
| 217 | NCT00184743 (ClinicalTrials.gov) | December 6, 2003 | 13/9/2005 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 65 Years | All | 112 | Phase 3 | Japan |
| 218 | NCT02693522 (ClinicalTrials.gov) | October 2003 | 19/1/2016 | Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency | Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: somatropin;Drug: Eutropin | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 18 Years | N/A | Both | 52 | Phase 3 | Korea, Republic of |
| 219 | NCT01580605 (ClinicalTrials.gov) | July 17, 2003 | 13/4/2012 | French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin | Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 331 | France | |
| 220 | NCT01543880 (ClinicalTrials.gov) | July 2003 | 28/2/2012 | Safety and Efficacy of Long-term Somatropin Treatment in Adults | Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 20 Years | N/A | Both | 752 | N/A | Germany |
| 221 | NCT00600808 (ClinicalTrials.gov) | June 2003 | 23/7/2007 | Sustained Release Formulation of Somatropin (rDNA Origin)for Injection | A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency. | Growth Hormone Deficiency | Drug: BPLG-003 | BioPartners GmbH | LG Life Sciences | Completed | 4 Years | 10 Years | Both | 51 | Phase 2/Phase 3 | NULL |
| 222 | NCT00476385 (ClinicalTrials.gov) | June 2003 | 21/5/2007 | Practicability and Acceptability of Stylomax® in Children | Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children. | Growth Hormone Deficiency | Drug: somatropine | Sanofi | NULL | Completed | 3 Years | 18 Years | Both | 12 | Phase 3 | France |
| 223 | NCT00519558 (ClinicalTrials.gov) | May 31, 2003 | 20/8/2007 | Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 65 Years | All | 121 | Phase 3 | Japan |
| 224 | NCT00567385 (ClinicalTrials.gov) | March 10, 2003 | 30/11/2007 | Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 18 Years | All | 176 | Phase 4 | Turkey |
| 225 | NCT00191360 (ClinicalTrials.gov) | January 2003 | 12/9/2005 | Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency | Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | NULL | Completed | 18 Years | 65 Years | Both | 68 | Phase 3 | Japan |
| 226 | NCT00638053 (ClinicalTrials.gov) | November 2002 | 11/3/2008 | A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury | Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury | Brain Injuries;Growth Hormone Deficiency Dwarfism | Genetic: somatropin | Pfizer | NULL | Terminated | 18 Years | N/A | Both | 100 | Phase 4 | United States |
| 227 | NCT01088399 (ClinicalTrials.gov) | September 2002 | 25/2/2010 | A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults | The Global Hypopituitary Control and Complications Study | Hypopituitarism;Pituitary Insufficiency;Growth Hormone Deficiency, Adult | Drug: Somatropin (rDNA origin) | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 10673 | N/A | NULL |
| 228 | NCT01009905 (ClinicalTrials.gov) | June 24, 2002 | 5/11/2009 | An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) | Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone | Growth Hormone Disorder;Pituitary Dwarfism;Hypopituitarism | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 18 Years | All | 22960 | N/A | United States |
| 229 | NCT00184678 (ClinicalTrials.gov) | February 2002 | 13/9/2005 | Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency | Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 25 Years | All | 161 | Phase 3 | Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom |
| 230 | NCT00136032 (ClinicalTrials.gov) | January 2002 | 24/8/2005 | Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women | Gender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin;Drug: Placebo | Massachusetts General Hospital | NULL | Completed | 18 Years | 65 Years | Female | 63 | N/A | United States |
| 231 | NCT01698944 (ClinicalTrials.gov) | May 16, 2001 | 1/10/2012 | Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency | Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Terminated | 12 Years | 25 Years | All | 7 | Phase 4 | Greece |
| 232 | NCT01502124 (ClinicalTrials.gov) | May 8, 2001 | 29/12/2011 | Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency | Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 17 Years | All | 78 | Phase 3 | United States |
| 233 | NCT01543867 (ClinicalTrials.gov) | January 2001 | 28/2/2012 | Safety and Efficacy of Long-term Somatropin Treatment in Children | Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA) | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Foetal Growth Problem;Small for Gestational Age;Genetic Disorder;Turner Syndrome;Growth Disorder;Idiopathic Short Stature | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 18 Years | Both | 5442 | N/A | Germany |
| 234 | NCT01563926 (ClinicalTrials.gov) | October 23, 2000 | 23/3/2012 | Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 168 | Phase 3 | Israel |
| 235 | NCT00262249 (ClinicalTrials.gov) | August 2000 | 5/12/2005 | Effect of Growth Hormone in Children With Growth Hormone Deficiency | Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Growth Disorder;Idiopathic Short Stature | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 15 Years | All | 173 | Phase 3 | United States |
| 236 | NCT00931476 (ClinicalTrials.gov) | April 6, 2000 | 30/6/2009 | A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin | A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24) | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Healthy | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 20 Years | 50 Years | Male | 86 | Phase 1 | United States |
| 237 | NCT00490191 (ClinicalTrials.gov) | January 1999 | 20/6/2007 | Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency | Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency | Hypopituitarism | Drug: Somatropin | Eli Lilly and Company | NULL | Completed | 20 Years | N/A | Both | 387 | Phase 4 | United States;France;Germany;Italy;Puerto Rico;United Kingdom |
| 238 | NCT01562834 (ClinicalTrials.gov) | October 21, 1998 | 22/3/2012 | Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients | Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 50 Years | All | 22 | Phase 4 | France |
| 239 | NCT00570011 (ClinicalTrials.gov) | June 1997 | 7/12/2007 | Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients | Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients | Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | University of Naples;University of Padua;University of Milan;University of Pisa | Completed | 18 Years | N/A | Both | 112 | Phase 3 | United States |
| 240 | NCT00174278 (ClinicalTrials.gov) | February 1997 | 9/9/2005 | Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary | Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety. | Growth Hormone Deficiency;Growth Retardation | Drug: Somatropin | Pfizer | NULL | Completed | 6 Years | N/A | Both | 14 | Phase 3 | France |
| 241 | EUCTR2016-003874-42-FR (EUCTR) | 06/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | |||
| 242 | EUCTR2018-000231-27-FR (EUCTR) | 25/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Norway;Germany;Algeria;Japan;Korea, Republic of | |||
| 243 | EUCTR2009-017354-12-NL (EUCTR) | 30/07/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | NA | Female: yes Male: yes | 130 | Phase 3 | Czech Republic;Slovakia;Germany;Netherlands;United Kingdom;Sweden | |||
| 244 | EUCTR2018-000231-27-NO (EUCTR) | 14/11/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 245 | EUCTR2016-003874-42-PL (EUCTR) | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | |||
| 246 | EUCTR2017-000914-47-Outside-EU/EEA (EUCTR) | 23/05/2017 | Growth hormone treatment in children born small for gestational age (SGA) | A long-term, multi-centre, randomised, controlled, double-blind, parallel-group trial, investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational ageExtension to trial GHLiquid-1516: A 104-week, multi-centre, randomised, double-blind, parallel-group, no treatment controlled (open-label) trial investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational age | Foetal growth problemSmall for Gestational AgeGrowth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NN-220 INN or Proposed INN: SOMATROPIN Other descriptive name: SOMATROPIN Product Name: NN-220 INN or Proposed INN: SOMATROPIN Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 86 | Phase 3 | Japan | |||
| 247 | EUCTR2013-000013-20-FR (EUCTR) | 25/09/2015 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 32 | Phase 1 | France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 248 | EUCTR2016-000446-56-Outside-EU/EEA (EUCTR) | 07/03/2016 | Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. | Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. - CERES | Growth deficiency due to growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NA Product Code: NA INN or Proposed INN: NA Other descriptive name: SOMATROPIN Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: NA Other descriptive name: SOMATROPIN | Cristália Produtos Químicos Farmacêuticos Ltda. | NULL | NA | Female: yes Male: yes | 94 | Brazil | ||||
| 249 | EUCTR2016-001145-11-BG (EUCTR) | 11/01/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | |||
| 250 | EUCTR2018-000231-27-IE (EUCTR) | 26/11/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 251 | EUCTR2012-002787-27-FR (EUCTR) | 23/09/2015 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | |||
| 252 | EUCTR2013-004468-69-RO (EUCTR) | 02/06/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | NA | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 253 | EUCTR2010-019374-32-DE (EUCTR) | 07/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Germany will be used in this clinical trial Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Czech Republic;Slovakia;Germany;Slovenia |