DDrare: Database of Drug Development for Rare Diseases

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.

Drug = ACP-001; ACP-001 (TransCon hGH); AEZS-130; AEZS-130 (formerly ARD-07); AGUA PARA PREPARACIONES INYECTABLES; ALRN-5281 0.015 mg/kg; ALRN-5281 0.05 mg/kg; ALRN-5281 0.15 mg/kg; ALTU-238; ANASTROZOLE; ARX201; Acetate; Acipimox; Albutropin; Amitriptyline; Amitriptyline, fluoxetine and tramadol alone (control group); Anastrozole; Arg; Arginin; Arginine; Aricept; Arimidex; Arimidex (Anastrozole); BPLG-003; CLONIDINE HYDROCHLORIDE; Caffeine; Catapresan; Change in daily dosage of Growth Hormone; Chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001); Chloride; CinnaTropin®; Clonidin; Clonidine; Clonidine HCl CF 0,150 mg, tabletten; Corticotropin; DGH; Daily hGH; Daily rhGH; Device: NuSpin; Device: hGH-ViaDerm™ System; Dextromethorphan; Dextromethorphan and Caffeine; Donepezil; Dose-Establishing Study 1 Niacin 250mg; Dose-Establishing Study 1 Niacin 500mg; Dose-Establishing Study 2 Niacin 500mg; Ecombinanat DNA-derived human growth h; Emcitate; Essential Amino Acid (EAA) group; Eutropin; Experimental: VRS-317; Fat diet; Fluoxetine; GENOTROPIN 12 mg powder and solvent for solution for injection.; GH substitution; GHRH; GROWTH HORMONE; GX-H9; Gelatin; Genetic: somatropin; Genotonorm Kabipen 5.3 mg polvo y disolvente para sol. inyectable (Marca internacional Genotropin); Genotonorm Kabipen 5.3 mg polvo y disolvente para solución inyectable (Marca internacional Genotropin); Genotropin; Genotropin (PN-180,307) Somatropin; Genotropin 12 mg; Genotropin 12 mg/ml; Genotropin 12mg; Genotropin 5 mg/ml; Genotropin 5.3 mg in injection system Genotropin pen; Genotropin 5.3mg; Genotropin GoQuick; Genotropin Mark VII pen; Genotropin MiniQuick; Genotropin Miniqu; Genotropin Miniquick 0.2mg; Genotropin Miniquick 0.4mg; Genotropin Miniquick 0.6mg; Genotropin Miniquick 0.8mg; Genotropin Miniquick 1.0mg; Genotropin Miniquick 1.2mg; Genotropin miniquick 0.5 mg, injection; Genotropin, Genotropin MiniQuick; Genotropin/GENOTONORM®; Genotropin®; Ghrelin; Glucagon; Growth Hormone; Growth Hormone Replacement Therapy; Growth Hormone, GH; Growth Hormone-Releasing Hormone; Growth hormone; Growth hormone (Genotonorm® or Omnitrope®); Growth hormone (Genotropin); Growth hormone (Nutropin); Growth hormone (genotropin); Growth hormone (somatropin); Growth hormone - LB03002; Growth hormone administration for 6 months; Growth hormone releasing hormone (GHRH) 1-44; Growth hormone releasing hormone (GHRH) and arginine; Growth hormone replacement therapy in growth hormone deficient patients only.; H01AC01; HGH; HGH-ViaDerm™ System (hGH or somatropin); HGH-hyFc, recombinant human growth hormone; HM10560A; HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH); HYDROCORTISONE; Human Growth Hormone; Human Growth Hormone (1-134); Human Serum Albumin (HSA) fused to somatropin; Human acylated ghrelin; Human growth hormone; Human serum albumin; Humatrope; Hydrocortisone; Hydrocortisone TAKEDA, tabletter; Hydrocortone; Hydrokortison Glostrup 5 mg; INCRELEX; INCRELEX 10 mg/ml; INCRELEX 10 mg/ml, solución inyectable; INSULIN; Increlex; Insulin; Jintropin AQ; L-ARG+GHRH; L-Arg; LB03002; LUM-201; Levothyroxine; Lonapegsomatropin; MACIMORELIN ACETATE; MECASERMINA; MOD-4023; Macimorelin; Macimorelin acetate; Macrilen; Mecasermin; Mecasermina; NN-220; NN8630; NNC 126-0083; NNC0195-0092; NNC0195-0092 10 mg/1.5 ml PDS290-10; NNC0195-0092 15 mg/1.5 ml PDS290-15; NNC0195-0092 5 mg/1.5 ml PDS290-10; NNC0195-0092 DP 6.7 mg ml 3 ml cartridge; NNC0195-0092 PDS290 10 mg-1.5 ml; NNC0195-0092 PDS290 10 mg/1.5 ml; NNC126-0083; NUTROPIN; NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable; Niacin; Niacin First; None; NordiFlex; Nordilet®; Norditropin; Norditropin FlexPro 10 mg; Norditropin FlexPro 10 mg/1.5 ml; Norditropin Growth Hormone; Norditropin NordiFlex®; Norditropin NordiFlex® 10 mg/1.5 ml; Norditropin NordiFlex® 10mg/1.5 ml; Norditropin SimpleXx; Norditropin SimpleXx (growth hormone); Norditropin SimpleXx 10 mg; Norditropin SimpleXx 5mg/1.5ml; Norditropin Simplex; Norditropin SimplexX; Norditropin SimplexX (5mg/1,5 ml) (INN:somatropin); Norditropin®; Norditropin® FlexPro®; Norditropin® FlexPro® pen; Norditropin® SimpleXx® 5 mg/1.5ml; Nutritional supplementation standardized formula; Nutropin AQ; Nutropin Aq; NutropinAq; NutropinAq 10 mg/2 ml; NutropinAq 10 mg/2 ml (30 UI); OMNITROPE; Oestrogen; Omnitrop; Omnitrope; Omnitrope®; Once daily subcutaneous injection of Genotropin; Once weekly subcutaneous injection of TransCon hGH; Only medicinal products registered in Austria will be used in this clinical trial.; Only medicinal products registered in Germany will be used in this clinical trial; Other: 2h standardized aerobic exercise; Other: GH pause; Other: GHRH plus arginine test; Other: GHRH+Arg, GHRH+Arg, ITT; Other: Growth hormone; Other: ITT, ITT, GHRH+Arg.; Other: No treatment given; Other: corticotropin releasing hormone (CRH); Other: levothyroxine; PEG; PEG-somatropin; PF-06836922; PHA-794,428; PHA-794428; PN-180307; Pegvisomant; Pegylated Somatropin; Pegylated polypeptide hormone of human recombinant origin PEG-hGH; Pegylated recombinant human growth hormone; Pegylated somatropin; Phosphate; Phosphate sandoz; Pioglitazone; Plenadren 20 mg modified-release tablets; Plenadren 5 mg modified-release tablets; Procedure: 9% Sodium Chloride (NaCl) IV; Procedure: Arginine and Clonidine Stimulation Testing; Procedure: Audiological and ear, nose and throat examination; Procedure: Behavior and neuropsychometric evaluations; Procedure: Blood draws; Procedure: Carotid ultrasound; Procedure: DEXA, blood tests, H.G.P.O, osseous age.; Procedure: Dental evaluation; Procedure: Determination of growth hormone status; Procedure: Dysmorphology evaluation; Procedure: Endothelial cell biopsy; Procedure: GHRH/arginine stimulation testing; Procedure: Gastrointestinal evaluation; Procedure: Glucagon stimulation test and insulin tolerance test; Procedure: Growth Factors Laboratory Testing; Procedure: MRI; Procedure: Magnetic resonance imaging of the brain; Procedure: Measurement of growth, thyroid and sex hormone levels; Procedure: Neurology examination; Procedure: Neuropsychological Testing; Procedure: Ophthalmologic evaluation; Procedure: Orthopedic evaluation; Procedure: Psychiatric evaluation; Procedure: Speech pathology evaluation; Procedure: arginine stimulation test after each limb; Procedure: biopsy; Procedure: glucagon stimulation test and insulin tolerance test; R-hGH; R-hGH freeze-dried; R-hGH liquid (Saizen); RECOMBINANT HUMAN GROWTH HORMONE; RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH); RVG 15790 or RVG 25480; Recombinanat DNA-derived human growth; Recombinanat DNA-derived human growth hormone produced in E.coli; Recombinant DNA-derived human growth hormone; Recombinant DNA-derived human growth hormone produced in E.coli; Recombinant Growth Hormone, Genotropin (Pfizer); Recombinant Human Gowth Hormone; Recombinant Human Growth Hormone; Recombinant growth hormone; Recombinant human Growth Hormone; Recombinant human Growth Hormone (Genotropin® ); Recombinant human Growth Hormone (rhGH); Recombinant human Growth Hormone(rhGH); Recombinant human IGF-1; Recombinant human growth hormone; Recombinant human growth hormone (r-hGH); Recombinant human growth hormone (rhGH); Recombinant human somatotropin; Recombinat human growth hormone; Regular insulin; RhGH; RhGH Norditropin® FlexPro® pen (34 µg/kg); Routine transdermal oestrogen patch; SAIZEN; SOMAPACITAN; SOMATROPIN; SOMATROPIN FOR INJECTION; SOMATROPINA; STERILISED WATER FOR INJECTIONS; Saizen; Saizen 8mg click.easy powder for solution for injection; Saizen 8mg click.easy power for solution for injection; Saizen®; Saizen® solution for injection (referred as Saizen®); Saline; Sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group); Serum albumin; Sodium chloride; Somapacitan; Somapacitan 10 mg/1.5ml PDS290; Somapacitan 15 mg/1.5ml PDS290; Somapacitan 5 mg/1.5ml PDS290; Somatorelin; Somatostatin; Somatotropin; Somatotropine; Somatrogon; Somatrogon (Genetical Recombination); Somatropin; Somatropin (INN) recombinant DNA orgin, Escherichia coli; Somatropin (rDNA origin); Somatropin AQ; Somatropin Injection; Somatropin injection; Somatropina; Somatropine; Somavaratan; Somavaratan (VRS-317); Sterile Water; Sterile Water for Injection; Strontium ranelate; Sustained release growth hormone; Sustained-release recombinant human GH (SR-rhGH); Synacthen; Synacthen (Tetracosactrin); Syntropin; TIRATRICOL; TJ101; TRANSCON PEG40 HGH; TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug; TV-1106; TV1106; Tesamorelin; Testogel; Testosterone; Testosterone plus somatropin; Tetracosactrin; TheraDerm; Thyroid; Thyroxin, Triiodothyronine; Tiratricol; Tramadol; TransCon hGH; TransCon hGH (ACP-011); TransCon hGH (ACP-011) - 12,1mg; TransCon hGH (ACP-011) - 12.1mg; TransCon hGH (ACP-011) - 24.2mg; TransCon hGH CT-301 (ACP-011) - 12,1mg; Transdermal Testosterone gel; Transiently PEGylated hGH prodrug; Triiodothyronine; Trisequens; VRS-317; Water; Y-shape pegylated somatropin; ZD1033; Zomacton; Zomacton 10 mg/ml

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	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
2	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
3	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
4	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
5	NCT03878992 (ClinicalTrials.gov)	April 30, 2019	7/3/2019	Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle	Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle	Growth Hormone Deficiency;Growth Hormone Treatment	Drug: Genotropin miniquick 0.5 mg, injection	University of Aarhus	Aarhus University Hospital	Recruiting	18 Years	100 Years	All	12	N/A	Denmark
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
6	NCT03831880 (ClinicalTrials.gov)	February 7, 2019	21/12/2018	Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD	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 (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY	Growth Hormone Deficiency	Drug: Genotropin;Drug: somatrogon	Pfizer	NULL	Completed	3 Years	17 Years	All	87	Phase 3	United States;Bulgaria;Czechia;Slovakia;United Kingdom
7	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
8	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
9	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]		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;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand
10	NCT03874013 (ClinicalTrials.gov)	December 7, 2017	1/10/2018	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	Growth Hormone Deficiency	Drug: MOD-4023;Drug: Genotropin	OPKO Health, Inc.	NULL	Completed	3 Years	11 Years	All	44	Phase 3	Japan
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
11	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]		OPKO Biologics Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 3	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
12	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]		OPKO Biologics Ltd.	NULL	Not Recruiting			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
13	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
14	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]		OPKO Biologics Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 3	Germany;New Zealand;United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia
15	EUCTR2016-001145-11-IT (EUCTR)	07/04/2017	10/01/2017	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: 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/S	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	South 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
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
16	EUCTR2016-001145-11-PL (EUCTR)	31/03/2017	17/01/2017	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 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/S	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	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
17	NCT02781727 (ClinicalTrials.gov)	December 13, 2016	19/5/2016	A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in 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, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary Diseases	Drug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of Genotropin	Ascendis Pharma A/S	NULL	Completed	3 Years	12 Years	All	161	Phase 3	United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine
18	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
19	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
20	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
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
21	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
22	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
23	NCT03309891 (ClinicalTrials.gov)	January 18, 2016	5/9/2017	Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency	A Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone Deficiency	Growth Hormone Deficiency	Drug: GX-H9;Drug: Genotropin	Genexine, Inc.	NULL	Completed	3 Years	11 Years	All	56	Phase 2	Ukraine
24	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
25	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
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
26	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
27	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
28	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
29	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
30	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
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
31	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
32	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
33	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
34	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
35	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
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
36	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
37	EUCTR2014-002736-13-HU (EUCTR)	26/06/2015	10/04/2015	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: 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	Authorised-recruitment may be ongoing or finished			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;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
38	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
39	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
40	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
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
41	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
42	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
43	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
44	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
45	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
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
46	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
47	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
48	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
49	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
50	NCT02946606 (ClinicalTrials.gov)	January 2015	28/8/2015	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	Drug: GX-H9;Drug: Genotropin	Genexine, Inc.	NULL	Completed	20 Years	65 Years	All	45	Phase 2	Korea, Republic of
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
51	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
52	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
53	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
54	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
55	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
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
56	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 a	Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden
57	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
58	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
59	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 a	United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
60	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
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
61	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 a	France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden
62	EUCTR2012-005066-36-NL (EUCTR)	15/05/2013	23/01/2013	To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiency	Effect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors	Growth hormone deficiency;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Genotropin Trade Name: Norditropin Trade Name: Humatrope Trade Name: Zomacton	VU University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
63	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
64	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
65	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 a	France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden
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
66	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
67	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 a	United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden
68	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
69	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 a	United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden
70	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
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
71	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
72	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
73	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
74	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
75	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
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
76	NCT01822340 (ClinicalTrials.gov)	October 2011	25/3/2013	Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients	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	Drug: HM10560A;Drug: Genotropin	Hanmi Pharmaceutical Company Limited	NULL	Completed	23 Years	60 Years	Both	72	Phase 2	Hungary;Romania
77	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
78	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		Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	Czech Republic;Slovakia;Netherlands;Germany;United Kingdom;Sweden
79	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
80	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
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
81	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
82	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
83	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
84	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
85	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
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
86	EUCTR2009-016783-37-SE (EUCTR)	07/01/2010	16/10/2009	The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH	The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH	Growth hormone deficiency in adults	Product Name: Genotropin, Genotropin MiniQuick Product Code: H01AC01 INN or Proposed INN: recombinant human growth hormone	Sahlgrenska University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60		Sweden
87	NCT00884000 (ClinicalTrials.gov)	January 2010	17/4/2009	A Study of Zomacton in Children With Growth Hormone Deficiency	A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency	Growth Hormone Deficiency	Drug: Genotropin;Drug: Zomacton	Ferring Pharmaceuticals	NULL	Completed	3 Years	11 Years	Both	165	Phase 3	Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine
88	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
89	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
90	EUCTR2007-003586-41-IT (EUCTR)	04/03/2008	01/07/2008	PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND	PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND	Growth hormone deficiency (GHD)after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: Genotropin	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom;Netherlands;France;Spain;Italy;Sweden
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
91	NCT00646815 (ClinicalTrials.gov)	March 2008	19/2/2008	Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency	Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency	Growth Hormone Deficiency	Drug: growth hormone (genotropin)	University of Aarhus	Aarhus University Hospital	Completed	18 Years	60 Years	Both	24	N/A	Denmark
92	NCT00555009 (ClinicalTrials.gov)	March 2008	24/10/2007	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;Growth Hormone Deficiency	Drug: Genotropin;Drug: Placebo	Pfizer	NULL	Terminated	18 Years	55 Years	All	10	Phase 4	France;Italy;Netherlands;Spain;Sweden;United Kingdom
93	EUCTR2007-003586-41-FR (EUCTR)	13/02/2008	14/11/2007	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: Genotropin/GENOTONORM® Product Name: Genotropin/GENOTONORM®	Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom;Netherlands;France;Spain;Italy;Sweden
94	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
95	EUCTR2007-003586-41-NL (EUCTR)	17/12/2007	09/08/2007	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: Genotropin Product Name: Genotropin	Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom;Netherlands;France;Spain;Italy;Sweden
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
96	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120		United Kingdom;Netherlands;France;Spain;Italy;Sweden
97	EUCTR2007-003586-41-SE (EUCTR)	21/11/2007	12/09/2007	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: Genotropin Product Name: Genotropin	Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom;Netherlands;France;Spain;Italy;Sweden
98	EUCTR2007-003586-41-GB (EUCTR)	15/11/2007	11/10/2007	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A	Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: Genotropin Product Name: Genotropin	Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom;Netherlands;France;Spain;Italy;Sweden
99	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
100	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
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
101	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
102	EUCTR2006-001574-24-NL (EUCTR)	06/10/2006	15/06/2006	Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency	Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency	Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries	Trade Name: Genotropin Product Name: genotropin Product Code: RVG 15790 or RVG 25480	Radboud University Nijmegen Medical Centre, Department of Endocrinology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30		Netherlands
103	EUCTR2005-005613-38-IE (EUCTR)	31/05/2006	06/01/2006	Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk?	Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk?	Hypopituitarism refers to decreased secretion of pituitary hormones, which can result from diseases of the pituitary gland or from diseases of the hypothalamus, which cause diminished secretion of hypothalamic releasing hormones, thereby reducing secretion of the corresponding pituitary hormones.	Trade Name: Trisequens Trade Name: Testogel Trade Name: Genotropin MiniQuick	Dr. Chris Thompson	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Ireland
104	NCT00517062 (ClinicalTrials.gov)	January 2006	15/8/2007	Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates	Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient Adults	Growth Hormone Deficiency	Drug: Growth hormone (Genotropin);Drug: Placebo	Oregon Health and Science University	NULL	Completed	18 Years	75 Years	Both	16	Phase 0	United States
105	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
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
106	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
107	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
108	NCT00929799 (ClinicalTrials.gov)	November 2003	29/6/2009	Growth Hormone and Glucose Metabolism	Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency	Growth Hormone Deficiency	Drug: recombinant human Growth Hormone (Genotropin® )	Charite University, Berlin, Germany	NULL	Completed	18 Years	N/A	Both	6	Phase 4	Germany
109	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
110	NCT00462475 (ClinicalTrials.gov)	January 1996	18/4/2007	Effect of 5 Years of GH Replacement on Atherosclerosis	Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients	Hypopituitarism;Pituitary Tumors;Growth Hormone Deficiency	Drug: Recombinant Growth Hormone, Genotropin (Pfizer)	Federico II University	NULL	Completed	18 Years	50 Years	Male	20	Phase 4	Italy
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
111	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
112	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
113	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]		OPKO Biologics Ltd.	NULL	NA			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
114	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
115	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]		OPKO Biologics Ltd.	NULL	NA			Female: yes Male: yes	220	Phase 3	United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Georgia;Bulgaria;Germany;New Zealand
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
116	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

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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

Phase 3

United States;Czech Republic;Slovakia;Bulgaria;United Kingdom

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

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

Phase 3

United States;Czech Republic;Slovakia;Bulgaria;United Kingdom

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

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Czech Republic;Slovakia;Bulgaria;United Kingdom

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

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Czech Republic;Slovakia;Bulgaria;United Kingdom

NCT03878992
(ClinicalTrials.gov)

April 30, 2019

7/3/2019

Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle

Growth Hormone Deficiency;Growth Hormone Treatment

Drug: Genotropin miniquick 0.5 mg, injection

University of Aarhus

Aarhus University Hospital

Recruiting

18 Years

100 Years

All

N/A

Denmark

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

NCT03831880
(ClinicalTrials.gov)

February 7, 2019

21/12/2018

Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

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 (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Growth Hormone Deficiency

Drug: Genotropin;Drug: somatrogon

Pfizer

NULL

Completed

3 Years

17 Years

All

Phase 3

United States;Bulgaria;Czechia;Slovakia;United Kingdom

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

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

BOTH

Phase 3

Japan

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]

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;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand

NCT03874013
(ClinicalTrials.gov)

December 7, 2017

1/10/2018

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

Growth Hormone Deficiency

Drug: MOD-4023;Drug: Genotropin

OPKO Health, Inc.

NULL

Completed

3 Years

11 Years

All

Phase 3

Japan

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

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

OPKO Biologics Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 3

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

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

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]

OPKO Biologics Ltd.

NULL

Not Recruiting

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

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

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

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

OPKO Biologics Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 3

Germany;New Zealand;United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia

EUCTR2016-001145-11-IT
(EUCTR)

07/04/2017

10/01/2017

A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children

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/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

South 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

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

EUCTR2016-001145-11-PL
(EUCTR)

31/03/2017

17/01/2017

A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children

Ascendis Pharma Endocrinology Division A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

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

NCT02781727
(ClinicalTrials.gov)

December 13, 2016

19/5/2016

A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in 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, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary Diseases

Drug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of Genotropin

Ascendis Pharma A/S

NULL

Completed

3 Years

12 Years

All

161

Phase 3

United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine

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

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

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

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

Genexine, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

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

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

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

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]

Genexine, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of

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

Genexine, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

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

NCT03309891
(ClinicalTrials.gov)

January 18, 2016

5/9/2017

Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency

A Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone Deficiency

Growth Hormone Deficiency

Drug: GX-H9;Drug: Genotropin

Genexine, Inc.

NULL

Completed

3 Years

11 Years

All

Phase 2

Ukraine

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

EUCTR2014-002736-13-HR
(EUCTR)

09/12/2015

01/02/2016

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]

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

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

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

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]

Genexine, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia

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

Genexine, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia

EUCTR2014-002736-13-SI
(EUCTR)

15/10/2015

12/05/2015

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

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

Genexine, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia

EUCTR2014-002736-13-CZ
(EUCTR)

01/10/2015

10/09/2015

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

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

EUCTR2014-002736-13-IT
(EUCTR)

25/08/2015

27/04/2015

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

EUCTR2014-002736-13-LT
(EUCTR)

20/08/2015

14/05/2015

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

EUCTR2014-002736-13-DE
(EUCTR)

19/08/2015

13/03/2015

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

EUCTR2014-002736-13-ES
(EUCTR)

24/07/2015

08/05/2015

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

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

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]

Genexine, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of

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

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]

Genexine, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden

EUCTR2014-002736-13-HU
(EUCTR)

26/06/2015

10/04/2015

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]

Teva Pharmaceutical Industries Ltd.

NULL

Authorised-recruitment may be ongoing or finished

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;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden

EUCTR2014-002736-13-GR
(EUCTR)

26/06/2015

10/06/2015

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

EUCTR2014-002736-13-AT
(EUCTR)

22/06/2015

04/05/2015

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

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

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

Phase 2

Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden

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

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

Phase 2

Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

EUCTR2014-002736-13-SE
(EUCTR)

25/05/2015

21/04/2015

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

EUCTR2014-002736-13-SK
(EUCTR)

20/05/2015

15/01/2016

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]

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

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

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]

Genexine, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden

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).

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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

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

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

Phase 2

Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden

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

Genexine, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden

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).

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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

Genexine, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden

NCT02946606
(ClinicalTrials.gov)

January 2015

28/8/2015

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

Drug: GX-H9;Drug: Genotropin

Genexine, Inc.

NULL

Completed

20 Years

65 Years

All

Phase 2

Korea, Republic of

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

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

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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).

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]

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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).

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia

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

Phase 2

Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India

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

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany

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

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

Phase a

Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden

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).

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden

EUCTR2012-002787-27-SI
(EUCTR)

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

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]

Ascendis Pharma A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany

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).

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase a

United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden

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

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]

Ascendis Pharma A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany

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

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).

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]

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase a

France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden

EUCTR2012-005066-36-NL
(EUCTR)

15/05/2013

23/01/2013

To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiency

Effect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors

Growth hormone deficiency;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Genotropin
Trade Name: Norditropin
Trade Name: Humatrope
Trade Name: Zomacton

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

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

Ascendis Pharma A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany

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

United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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).

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase a

France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden

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

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

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

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany

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).

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase a

United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden

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

Ascendis Pharma A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany

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).

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase a

United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden

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

United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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

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]

PROLOR Biotech Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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

Hanmi Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India

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

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

Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel

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

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

United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia

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

Phase 2

Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation

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

NCT01822340
(ClinicalTrials.gov)

October 2011

25/3/2013

Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients

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

Drug: HM10560A;Drug: Genotropin

Hanmi Pharmaceutical Company Limited

NULL

Completed

23 Years

60 Years

Both

Phase 2

Hungary;Romania

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

Hanmi Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India

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

Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 3

Czech Republic;Slovakia;Netherlands;Germany;United Kingdom;Sweden

EUCTR2009-017354-12-SE
(EUCTR)

11/10/2010

09/04/2010

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

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)

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

Phase 2

Hungary;Germany;Czech Republic;Slovakia;Slovenia

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

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)

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

Phase 2

Hungary;Germany;Czech Republic;Slovakia;Slovenia

EUCTR2009-017354-12-DE
(EUCTR)

29/07/2010

08/06/2010

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

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)

Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

ModigeneTech Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;Czech Republic;Slovakia;Slovenia

EUCTR2009-017354-12-CZ
(EUCTR)

22/06/2010

14/04/2010

Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

130

United Kingdom;Germany;Czech Republic;Sweden

EUCTR2009-017354-12-SK
(EUCTR)

09/06/2010

26/05/2010

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

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

EUCTR2009-016783-37-SE
(EUCTR)

07/01/2010

16/10/2009

The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH

Growth hormone deficiency in adults

Product Name: Genotropin, Genotropin MiniQuick
Product Code: H01AC01
INN or Proposed INN: recombinant human growth hormone

Sahlgrenska University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Sweden

NCT00884000
(ClinicalTrials.gov)

January 2010

17/4/2009

A Study of Zomacton in Children With Growth Hormone Deficiency

A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency

Growth Hormone Deficiency

Drug: Genotropin;Drug: Zomacton

Ferring Pharmaceuticals

NULL

Completed

3 Years

11 Years

Both

165

Phase 3

Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine

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.

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

Ireland

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

EUCTR2007-003586-41-IT
(EUCTR)

04/03/2008

01/07/2008

PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND

Growth hormone deficiency (GHD)after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: Genotropin

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom;Netherlands;France;Spain;Italy;Sweden

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

NCT00646815
(ClinicalTrials.gov)

March 2008

19/2/2008

Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

Growth Hormone Deficiency

Drug: growth hormone (genotropin)

University of Aarhus

Aarhus University Hospital

Completed

18 Years

60 Years

Both

N/A

Denmark

NCT00555009
(ClinicalTrials.gov)

March 2008

24/10/2007

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;Growth Hormone Deficiency

Drug: Genotropin;Drug: Placebo

Pfizer

NULL

Terminated

18 Years

55 Years

All

Phase 4

France;Italy;Netherlands;Spain;Sweden;United Kingdom

EUCTR2007-003586-41-FR
(EUCTR)

13/02/2008

14/11/2007

Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A

Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: Genotropin/GENOTONORM®
Product Name: Genotropin/GENOTONORM®

Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom;Netherlands;France;Spain;Italy;Sweden

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

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

Germany

EUCTR2007-003586-41-NL
(EUCTR)

17/12/2007

09/08/2007

Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A

Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: Genotropin
Product Name: Genotropin

Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom;Netherlands;France;Spain;Italy;Sweden

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

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

United Kingdom;Netherlands;France;Spain;Italy;Sweden

EUCTR2007-003586-41-SE
(EUCTR)

21/11/2007

12/09/2007

Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A

Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: Genotropin
Product Name: Genotropin

Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom;Netherlands;France;Spain;Italy;Sweden

EUCTR2007-003586-41-GB
(EUCTR)

15/11/2007

11/10/2007

Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A

Growth hormone deficiency after traumatic brain injury
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: Genotropin
Product Name: Genotropin

Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom;Netherlands;France;Spain;Italy;Sweden

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

Phase 4

NULL

100

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

All

230

N/A

NULL

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

101

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

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

102

EUCTR2006-001574-24-NL
(EUCTR)

06/10/2006

15/06/2006

Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency

Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries

Trade Name: Genotropin
Product Name: genotropin
Product Code: RVG 15790 or RVG 25480

Radboud University Nijmegen Medical Centre, Department of Endocrinology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

103

EUCTR2005-005613-38-IE
(EUCTR)

31/05/2006

06/01/2006

Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk?

Hypopituitarism refers to decreased secretion of pituitary hormones, which can result from diseases of the pituitary gland or from diseases of the hypothalamus, which cause diminished secretion of hypothalamic releasing hormones, thereby reducing secretion of the corresponding pituitary hormones.

Trade Name: Trisequens
Trade Name: Testogel
Trade Name: Genotropin MiniQuick

Dr. Chris Thompson

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Ireland

104

NCT00517062
(ClinicalTrials.gov)

January 2006

15/8/2007

Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates

Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient Adults

Growth Hormone Deficiency

Drug: Growth hormone (Genotropin);Drug: Placebo

Oregon Health and Science University

NULL

Completed

18 Years

75 Years

Both

Phase 0

United States

105

EUCTR2005-000346-36-FI
(EUCTR)

22/09/2005

30/05/2005

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

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 3

Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden

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

106

EUCTR2005-000346-36-SE
(EUCTR)

18/08/2005

16/06/2005

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

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 3

Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden

107

EUCTR2005-000346-36-DE
(EUCTR)

16/08/2005

06/06/2006

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

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden

108

NCT00929799
(ClinicalTrials.gov)

November 2003

29/6/2009

Growth Hormone and Glucose Metabolism

Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency

Growth Hormone Deficiency

Drug: recombinant human Growth Hormone (Genotropin® )

Charite University, Berlin, Germany

NULL

Completed

18 Years

N/A

Both

Phase 4

Germany

109

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

110

NCT00462475
(ClinicalTrials.gov)

January 1996

18/4/2007

Effect of 5 Years of GH Replacement on Atherosclerosis

Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients

Hypopituitarism;Pituitary Tumors;Growth Hormone Deficiency

Drug: Recombinant Growth Hormone, Genotropin (Pfizer)

Federico II University

NULL

Completed

18 Years

50 Years

Male

Phase 4

Italy

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

111

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

Ascendis Pharma A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany

112

EUCTR2009-017354-12-NL
(EUCTR)

30/07/2010

Subjects with Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Female: yes
Male: yes

130

Phase 3

Czech Republic;Slovakia;Germany;Netherlands;United Kingdom;Sweden

113

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

OPKO Biologics Ltd.

NULL

Female: yes
Male: yes

220

Phase 3

114

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

Female: yes
Male: yes

Brazil

115

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

OPKO Biologics Ltd.

NULL

Female: yes
Male: yes

220

Phase 3

United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Georgia;Bulgaria;Germany;New Zealand

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

116

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

Teva Pharmaceutical Industries, Ltd.

NULL

Female: yes
Male: yes

Phase 2

Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia