Recombinant dna-derived human growth hormone    (DrugBank: Growth hormone, Human growth hormone)

2 diseases
IDDisease name (Link within this page)Number of trials
78Hypopituitarism39
187Kabuki syndrome1

78. Hypopituitarism    [ 462 clinical trials,   346 drugs,   (DrugBank: 45 drugs),   41 drug target genes,   80 drug target pathways]
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
39 / 462 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001145-11-DE
(EUCTR)
12/02/201814/12/2016A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Lebanon;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
2EUCTR2016-001145-11-IT
(EUCTR)
07/04/201710/01/2017A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenA 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
INN or Proposed INN: Sterile Water
Other descriptive name: STERILISED WATER FOR INJECTIONS
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3South Africa;Lithuania;Turkey;United Kingdom;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden
3EUCTR2016-001145-11-PL
(EUCTR)
31/03/201717/01/2017A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal childrenA 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
INN or Proposed INN: lonapegsomatropin
Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Belarus;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
4EUCTR2015-001939-21-LV
(EUCTR)
15/08/201631/05/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
5EUCTR2015-001939-21-LT
(EUCTR)
04/05/201629/02/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-001939-21-PL
(EUCTR)
19/04/201618/01/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of
7EUCTR2015-001939-21-EE
(EUCTR)
30/03/201616/02/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
8EUCTR2015-001939-21-GR
(EUCTR)
12/11/201513/10/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia
9EUCTR2015-001939-21-SK
(EUCTR)
22/10/201527/07/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia
10EUCTR2015-001939-21-CZ
(EUCTR)
14/10/201510/07/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-001939-21-HU
(EUCTR)
16/07/201522/05/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of
12EUCTR2014-002698-13-PL
(EUCTR)
30/06/201522/05/2015A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
13EUCTR2014-002698-13-DE
(EUCTR)
11/06/201523/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
14EUCTR2014-002698-13-GR
(EUCTR)
26/02/201517/03/2015A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
15EUCTR2014-002698-13-HU
(EUCTR)
17/02/201515/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-002698-13-SE
(EUCTR)
03/02/201518/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
17EUCTR2014-002698-13-SK
(EUCTR)
14/01/201509/12/2014A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
18EUCTR2011-001826-61-BG
(EUCTR)
07/02/201412/09/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA 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.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
19EUCTR2012-002787-27-BG
(EUCTR)
11/09/201303/06/2013A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany
20EUCTR2012-002787-27-SI
(EUCTR)
10/07/201310/07/2013A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2012-002787-27-DE
(EUCTR)
17/06/201319/12/2012A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
22EUCTR2012-002787-27-CZ
(EUCTR)
10/05/201319/12/2012A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
23EUCTR2011-004553-60-PL
(EUCTR)
02/04/201309/02/2012A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety 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.NULLNot RecruitingFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
24EUCTR2012-002787-27-GR
(EUCTR)
04/03/201315/02/2013A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
25EUCTR2012-002787-27-HU
(EUCTR)
11/02/201311/12/2012A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-004553-60-BG
(EUCTR)
02/07/201210/04/2012A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety 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.NULLNot RecruitingFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
27EUCTR2011-004553-60-CZ
(EUCTR)
10/04/201206/12/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
28EUCTR2011-001826-61-PL
(EUCTR)
25/01/201212/09/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA 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.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
29EUCTR2011-004553-60-GR
(EUCTR)
23/01/201227/12/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel
30EUCTR2011-004553-60-SK
(EUCTR)
10/01/201224/11/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-004553-60-HU
(EUCTR)
10/01/201203/11/2011A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Phase 2Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation
32EUCTR2011-001826-61-HU
(EUCTR)
29/07/201123/05/2011A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA 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.NULLNot RecruitingFemale: yes
Male: yes
65Phase 2Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India
33EUCTR2010-019374-32-AT
(EUCTR)
15/02/201129/12/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany
34EUCTR2010-019374-32-HU
(EUCTR)
13/09/201018/05/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
35EUCTR2010-019374-32-SI
(EUCTR)
13/09/201004/06/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2010-019374-32-CZ
(EUCTR)
06/09/201015/06/2010A study with MOD-4023 in patients with lack of Growth Hormone in the bodyA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel
37EUCTR2010-019374-32-SK
(EUCTR)
15/07/201014/05/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
38EUCTR2012-002787-27-FR
(EUCTR)
23/09/2015A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany
39EUCTR2010-019374-32-DE
(EUCTR)
07/12/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Czech Republic;Slovakia;Germany;Slovenia

187. Kabuki syndrome    [ 2 clinical trials,   7 drugs,   (DrugBank: 2 drugs),   3 drug target genes,   15 drug target pathways]
Searched query = "Kabuki syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 2 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000432-26-NL
(EUCTR)
26/09/201227/03/2012Prospective study on the metabolic and linear growth effects of growh hormone treatment in children with Kabuki SyndromeProspective study on the metabolic and linear growth effects of growh hormone treatment in children with Kabuki Syndrome - Metabolic effects of Growth Hormone Kabuki Syndrome (KS, OMIM 147920) with a mutation in MLL2 gene.
;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Maastricht University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands