78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
臨床試験数 : 492 / 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 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 | EUCTR2021-004313-39-GR (EUCTR) | 17/06/2022 | 18/04/2022 | An extension study to check the safety of once weekly lonapegsomatropin when given for a long time in adults with growth hormone deficiency. | A Multicenter, Open-Label, Extension Trial to Investigate Long TermEfficacy and Safety of Lonapegsomatropin in Adults with GrowthHormone Deficiency | 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 | 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 | ||
| 2 | EUCTR2020-000929-42-NL (EUCTR) | 14/04/2022 | 23/02/2021 | 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) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection Product Code: H01AC01 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;Turkey;Israel;United Kingdom;Italy;France;Armenia;Canada;Poland;Romania;Denmark;Australia;Georgia;Bulgaria;Netherlands;Germany;Japan;New Zealand | ||
| 3 | JPRN-jRCT2041210156 | 08/03/2022 | 05/03/2022 | A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults with Growth Hormone Deficiency | A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults with Growth Hormone Deficiency | Adult Growth Hormone Deficiency (AGHD) | Lonapegsomatropin will be provided as a lyophilized powder in single-use glass vials requiring reconstitution with 1 mL sWFI and administered by SC injection via syringe and needle Due to the different hGH dose requirements, depending on participants' age and receipt of concomitant oral estrogen, this trial will have three dosing groups. Participants will be initiated on a low dose, and the dose will slowly be increased to avoid adverse reactions as much as possible (Dose Titration Period) until the target maintenance dose is reached (Dose Maintenance Period). Dose Group 1 [Oral estrogen intake (any age) or below 30 years old] Week 1-4: 2.1 mg hGH/week, Week 5-8: 3.6 mg hGH/week, Week 9-12: 5.2 mg hGH/week, Week 13-52 (Dose Maintenance Period): 6.3 mg hGH/week Dose Group 2 [30 to 60 years old (both included) and no oral estrogen intake] Week 1-4: 1.4 mg hGH/week, Week 5-8: 2.1 mg hGH/week, Week 9-12: 3.0 mg hGH/week, Week 13-52 (Dose Maintenance Period): 4.3 mg hGH/week Dose Group 3 (Over 60 years old and no oral estrogen intake) Week 1-4: 0.7 mg hGH/week, Week 5-8: 1.4 mg hGH/week, Week 9-12: 2.1 mg hGH/week, Week 13-52 (Dose Maintenance Period): 3.0 mg hGH/week | Beckert Michael | NULL | Recruiting | >= 23age old | <= 81age old | Both | 24 | Phase 3 | USA;Japan |
| 4 | 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 | ||
| 5 | NCT05171855 (ClinicalTrials.gov) | December 16, 2021 | 24/9/2021 | A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency | A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency;Endocrine System Diseases;Hormone Deficiency | Drug: Lonapegsomatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Recruiting | 23 Years | 81 Years | All | 240 | Phase 3 | United States |
| 6 | 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 | ||
| 7 | 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 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 8 | JPRN-jRCT2031200340 | 14/06/2021 | 02/02/2021 | A trial to compare lonapegsomatropin (TransCon hGH) administered once a week and standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the efficacy, safety, and tolerability of lonapegsomatropin (TransCon hGH) administered once a week versus standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency(GHD) - riGHt | Pediatric growth hormon deficiency | Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. Genotropin will be administered as daily SC injections in a standard dose of 0.24 mg hGH/kg/week. The total weekly dose will be equally split into 7 daily doses of 0.034 mg hGH/kg/day. A commercially approved injection device will be used for administration of the drug. Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. | Beckert Michael | NULL | Recruiting | >= 3age old | <= 16age old | Both | 50 | Phase 3 | Japan |
| 9 | 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 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 10 | 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 |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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;New Zealand;Poland;Slovakia;Turkey;Ukraine |
| 15 | EUCTR2017-003410-20-RO (EUCTR) | 17/01/2019 | 13/05/2022 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | 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) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 16 | EUCTR2017-003410-20-IT (EUCTR) | 30/10/2018 | 11/10/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | 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) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany | ||
| 17 | EUCTR2017-003410-20-PL (EUCTR) | 23/10/2018 | 08/11/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | 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) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany | ||
| 18 | EUCTR2017-003410-20-GR (EUCTR) | 04/06/2018 | 19/04/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | 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) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 19 | EUCTR2017-003410-20-BG (EUCTR) | 20/04/2018 | 09/01/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | 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) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 |