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	NCT04614337 (ClinicalTrials.gov)	October 7, 2020	26/10/2020	Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)	A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)	Growth Hormone Deficiency	Drug: LUM-201;Drug: rhGH Norditropin® FlexPro® pen (34 µg/kg)	Lumos Pharma	NULL	Recruiting	3 Years	10 Years	All	80	Phase 2	United States
2	NCT03104010 (ClinicalTrials.gov)	April 2017	28/3/2017	A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD	A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)	Adult Growth Hormone Deficiency	Drug: Somatropin Injection	GeneScience Pharmaceuticals Co., Ltd.	Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China Hospital	Recruiting	18 Years	60 Years	All	180	Phase 2	China
3	EUCTR2014-004525-41-PL (EUCTR)	09/03/2016	23/02/2016	A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH.	Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY	Growth hormone deficiency 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: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE	Versartis, Inc.	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Canada;Belgium;Poland;Netherlands;Sweden
4	EUCTR2014-003796-32-PL (EUCTR)	08/01/2016	29/09/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Hungary;Mexico;Canada;Argentina;United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Lithuania;Austria;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany
5	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
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	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
7	EUCTR2014-003796-32-HR (EUCTR)	04/12/2015	01/02/2016	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
8	EUCTR2014-003796-32-RO (EUCTR)	18/11/2015	08/10/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
9	EUCTR2014-003796-32-SI (EUCTR)	15/10/2015	12/05/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Belarus;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
10	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
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	EUCTR2014-003796-32-BG (EUCTR)	07/10/2015	02/10/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
12	EUCTR2014-003796-32-CZ (EUCTR)	01/10/2015	14/04/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
13	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
14	EUCTR2014-004525-41-NL (EUCTR)	03/09/2015	23/03/2015	A Long-Acting Growth Hormone (VRS-317) in Children compared to Daily rhGH.	Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY	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: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE	Versartis, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	136	Phase 3	France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden
15	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
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	EUCTR2014-003796-32-IT (EUCTR)	25/08/2015	27/04/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Belarus;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
17	NCT02339090 (ClinicalTrials.gov)	August 24, 2015	7/1/2015	Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH	Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency.	Growth Disorders	Drug: somavaratan;Drug: Daily rhGH	Versartis Inc.	NULL	Completed	3 Years	11 Years	All	136	Phase 3	Belgium;Canada;Netherlands;Poland;Sweden;United States
18	EUCTR2014-003796-32-DE (EUCTR)	21/08/2015	16/03/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
19	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
20	EUCTR2014-003796-32-LT (EUCTR)	20/08/2015	14/05/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
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	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
22	EUCTR2014-003796-32-ES (EUCTR)	31/07/2015	08/05/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
23	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
24	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
25	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
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	EUCTR2014-003796-32-HU (EUCTR)	26/06/2015	10/04/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
27	EUCTR2014-003796-32-GR (EUCTR)	22/06/2015	15/06/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
28	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
29	EUCTR2014-003796-32-AT (EUCTR)	22/06/2015	29/04/2015	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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
30	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
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-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
32	EUCTR2014-003796-32-SK (EUCTR)	20/05/2015	15/01/2016	A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)	A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment	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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Serbia;Belarus;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	NCT02410356 (ClinicalTrials.gov)	April 30, 2015	30/3/2015	Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)	A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (dGH) in Adults With Growth Hormone-Deficiency	Growth Hormone Deficiency	Drug: TV-1106;Drug: dGH	Teva Pharmaceutical Industries, Ltd.	NULL	Terminated	18 Years	N/A	All	34	Phase 3	United States;Argentina;Austria;Czechia;Greece;Hungary;Italy;Mexico;Slovakia;Spain;Ukraine;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey
34	EUCTR2014-004525-41-BE (EUCTR)	22/04/2015	16/02/2015	A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH	Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY	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: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE	Versartis, Inc.	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Canada;Poland;Belgium;Netherlands;Sweden
35	EUCTR2014-004525-41-SE (EUCTR)	10/04/2015	12/02/2015	A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGH	Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY	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: Somavaratan (VRS-317) INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinat human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE	Versartis, Inc.	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Canada;Poland;Belgium;Netherlands;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
36	NCT02410343 (ClinicalTrials.gov)	April 2015	30/3/2015	Study of TV-1106 in Growth Hormone-Deficient Adults	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety, and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment	Growth Hormone Deficiency	Drug: TV-1106;Drug: Placebo	Teva Pharmaceutical Industries, Ltd.	NULL	Terminated	18 Years	N/A	All	14	Phase 3	United States;Argentina;Austria;Bulgaria;Greece;Hungary;Italy;Russian Federation;Spain;Ukraine;Brazil;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Serbia;Slovakia;Slovenia;Turkey
37	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
38	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
39	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
40	NCT01947907 (ClinicalTrials.gov)	July 2013	3/6/2013	Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)	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)	Drug: ACP-001;Drug: Human Growth Hormone	Ascendis Pharma A/S	NULL	Completed	3 Years	12 Years	All	53	Phase 2	Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine
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	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
42	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
43	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
44	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
45	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
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	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
47	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
48	EUCTR2010-020742-10-GB (EUCTR)	09/05/2011	04/11/2010	Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.	Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.	Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin	Ipsen Pharma	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Finland;United Kingdom;Spain;Sweden
49	EUCTR2010-020742-10-ES (EUCTR)	01/04/2011	07/01/2011	Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica	Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica	Niños pre-puberales con déficit idiopático de hormona de crecimiento MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable INN or Proposed INN: SOMATROPINA Other descriptive name: SOMATROPIN Trade Name: INCRELEX 10 mg/ml, solución inyectable INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES INN or Proposed INN: MECASERMINA Other descriptive name: MECASERMINA Trade Name: INCRELEX 10 mg/ml, solución inyectable INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES INN or Proposed INN: MECASERMINA Other descriptive name: MECASERMINA	Ipsen Pharma	NULL	Not Recruiting			Female: yes Male: yes	63		Finland;United Kingdom;Spain;Sweden
50	EUCTR2010-020742-10-SE (EUCTR)	23/02/2011	19/11/2010	Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].	Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.	Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin	Ipsen Pharma	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Finland;United Kingdom;Spain;Sweden
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	EUCTR2010-019374-32-AT (EUCTR)	15/02/2011	29/12/2010	A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)	A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)	Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Austria will be used in this clinical trial. Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone	ModigeneTech Ltd.	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 2	Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany
52	EUCTR2010-020742-10-FI (EUCTR)	10/01/2011	22/11/2010	Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].	Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.	Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin	Ipsen Pharma	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Finland;United Kingdom;Spain;Sweden
53	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
54	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
55	EUCTR2010-019374-32-CZ (EUCTR)	06/09/2010	15/06/2010	A study with MOD-4023 in patients with lack of Growth Hormone in the body	A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)	Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Product Name: n/a Product Code: MOD-4023 Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone	Prolor Biotech Ltd	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 2	Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel
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	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
57	NCT01605331 (ClinicalTrials.gov)	December 2009	22/5/2012	Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)		Growth Hormone Deficiency	Drug: sustained-release recombinant human GH (SR-rhGH)	LG Life Sciences	NULL	Completed	20 Years	N/A	Both	132	Phase 4	NULL
58	NCT00684957 (ClinicalTrials.gov)	January 2008	23/5/2008	Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors	Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency	Growth Hormone Deficiency	Drug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1	Columbia University	Tercica	Terminated	25 Years	65 Years	Male	5	N/A	United States
59	EUCTR2006-002278-24-SE (EUCTR)	15/05/2007	05/03/2007	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
60	EUCTR2006-002278-24-SK (EUCTR)	20/04/2007	22/03/2007	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	LG Life Sciences Ltd.	BioPartners GmbH	Not Recruiting			Female: yes Male: yes	150	Phase 3	France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
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	EUCTR2006-002278-24-FR (EUCTR)	13/04/2007	24/11/2006	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
62	EUCTR2006-002278-24-AT (EUCTR)	05/01/2007	10/11/2006	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	LG Life Sciences Ltd.	BioPartners GmbH	Not Recruiting			Female: yes Male: yes	150	Phase 3	United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
63	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
64	EUCTR2006-002278-24-CZ (EUCTR)	14/12/2006	08/09/2006	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
65	EUCTR2006-002278-24-ES (EUCTR)	13/12/2006	10/03/2010	Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
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	EUCTR2006-002278-24-DE (EUCTR)	06/10/2006	15/08/2006	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
67	EUCTR2005-000384-26-DE (EUCTR)	20/12/2005	02/06/2006	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United Kingdom;Czech Republic;Germany;Spain;Sweden
68	EUCTR2005-000384-26-AT (EUCTR)	10/11/2005	10/06/2005	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	LG Life Science Ltd.	BioPartners	Not Recruiting			Female: yes Male: yes	138	Phase 3	Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden
69	EUCTR2005-000384-26-SK (EUCTR)	27/10/2005	19/09/2005	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	138	Phase 3	Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden
70	EUCTR2005-000384-26-CZ (EUCTR)	30/09/2005	08/08/2005	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Germany;United Kingdom;Czech Republic;Spain;Sweden
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	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
72	EUCTR2005-000384-26-SE (EUCTR)	13/09/2005	27/06/2005	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.	Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	BioPartners GmbH	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Germany;United Kingdom;Czech Republic;Spain;Sweden
73	EUCTR2005-000384-26-ES (EUCTR)	22/08/2005	27/06/2005	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento	A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento	growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438	Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH)	LG Life Science Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	138	Phase 3	Germany;United Kingdom;Czech Republic;Spain;Sweden
74	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
75	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
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	NCT00458991 (ClinicalTrials.gov)	June 2001	9/4/2007	rhGH Therapy on Hepatic Drug Metabolism	Recombinant Human Growth Hormone Therapy and Drug Metabolism	Growth Hormone Deficiency, Dwarfism	Drug: Dextromethorphan and Caffeine	University of Louisville	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Completed	4 Years	14 Years	All	9	N/A	United States
77	NCT00497484 (ClinicalTrials.gov)	February 1995	5/7/2007	Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia)	Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia)	Pseudohypoparathyroidism;Growth Hormone Deficiency, Dwarfism	Drug: recombinant human somatotropin	University of Milan	Eli Lilly and Company	Active, not recruiting	1 Year	18 Years	Both		N/A	Italy
78	EUCTR2010-019374-32-DE (EUCTR)		07/12/2010	A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)	A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)	Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Germany will be used in this clinical trial Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone	ModigeneTech Ltd.	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 2	Hungary;Czech Republic;Slovakia;Germany;Slovenia
79	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

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

NCT04614337
(ClinicalTrials.gov)

October 7, 2020

26/10/2020

Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)

A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)

Growth Hormone Deficiency

Drug: LUM-201;Drug: rhGH Norditropin® FlexPro® pen (34 µg/kg)

Lumos Pharma

NULL

Recruiting

3 Years

10 Years

All

Phase 2

United States

NCT03104010
(ClinicalTrials.gov)

April 2017

28/3/2017

A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD

A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)

Adult Growth Hormone Deficiency

Drug: Somatropin Injection

GeneScience Pharmaceuticals Co., Ltd.

Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China Hospital

Recruiting

18 Years

60 Years

All

180

Phase 2

China

EUCTR2014-004525-41-PL
(EUCTR)

09/03/2016

23/02/2016

A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH.

Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY

Growth hormone deficiency
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: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE

Versartis, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Canada;Belgium;Poland;Netherlands;Sweden

EUCTR2014-003796-32-PL
(EUCTR)

08/01/2016

29/09/2015

A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product)

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

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: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Product Name: Albutropin
Product Code: TV-1106
INN or Proposed INN: Not available yet
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Hungary;Mexico;Canada;Argentina;United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Lithuania;Austria;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany

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

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

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-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

EUCTR2014-003796-32-HR
(EUCTR)

04/12/2015

01/02/2016

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Serbia;Belarus;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

EUCTR2014-003796-32-RO
(EUCTR)

18/11/2015

08/10/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

EUCTR2014-003796-32-SI
(EUCTR)

15/10/2015

12/05/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

United States;Belarus;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

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

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

EUCTR2014-003796-32-BG
(EUCTR)

07/10/2015

02/10/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

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

150

Phase 3

EUCTR2014-003796-32-CZ
(EUCTR)

01/10/2015

14/04/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

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

EUCTR2014-004525-41-NL
(EUCTR)

03/09/2015

23/03/2015

A Long-Acting Growth Hormone (VRS-317) in Children compared to Daily rhGH.

Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY

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: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE

Versartis, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Phase 3

France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden

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

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

EUCTR2014-003796-32-IT
(EUCTR)

25/08/2015

27/04/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

NCT02339090
(ClinicalTrials.gov)

August 24, 2015

7/1/2015

Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH

Growth Disorders

Drug: somavaratan;Drug: Daily rhGH

Versartis Inc.

NULL

Completed

3 Years

11 Years

All

136

Phase 3

Belgium;Canada;Netherlands;Poland;Sweden;United States

EUCTR2014-003796-32-DE
(EUCTR)

21/08/2015

16/03/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

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

EUCTR2014-003796-32-LT
(EUCTR)

20/08/2015

14/05/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

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-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

EUCTR2014-003796-32-ES
(EUCTR)

31/07/2015

08/05/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

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

EUCTR2014-002736-13-HU
(EUCTR)

26/06/2015

10/04/2015

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

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

EUCTR2014-003796-32-HU
(EUCTR)

26/06/2015

10/04/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Serbia;Belarus;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

EUCTR2014-003796-32-GR
(EUCTR)

22/06/2015

15/06/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

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

EUCTR2014-003796-32-AT
(EUCTR)

22/06/2015

29/04/2015

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

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

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-SK
(EUCTR)

20/05/2015

15/01/2016

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

EUCTR2014-003796-32-SK
(EUCTR)

20/05/2015

15/01/2016

A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

NCT02410356
(ClinicalTrials.gov)

April 30, 2015

30/3/2015

Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (dGH) in Adults With Growth Hormone-Deficiency

Growth Hormone Deficiency

Drug: TV-1106;Drug: dGH

Teva Pharmaceutical Industries, Ltd.

NULL

Terminated

18 Years

N/A

All

Phase 3

United States;Argentina;Austria;Czechia;Greece;Hungary;Italy;Mexico;Slovakia;Spain;Ukraine;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey

EUCTR2014-004525-41-BE
(EUCTR)

22/04/2015

16/02/2015

A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH

Product Name: VRS-317
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinant human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE

Versartis, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Canada;Poland;Belgium;Netherlands;Sweden

EUCTR2014-004525-41-SE
(EUCTR)

10/04/2015

12/02/2015

A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGH

Product Name: Somavaratan (VRS-317)
INN or Proposed INN: VRS-317
Other descriptive name: VRS-317
INN or Proposed INN: Recombinat human growth hormone
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE

Versartis, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Canada;Poland;Belgium;Netherlands;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

NCT02410343
(ClinicalTrials.gov)

April 2015

30/3/2015

Study of TV-1106 in Growth Hormone-Deficient Adults

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety, and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment

Growth Hormone Deficiency

Drug: TV-1106;Drug: Placebo

Teva Pharmaceutical Industries, Ltd.

NULL

Terminated

18 Years

N/A

All

Phase 3

United States;Argentina;Austria;Bulgaria;Greece;Hungary;Italy;Russian Federation;Spain;Ukraine;Brazil;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Serbia;Slovakia;Slovenia;Turkey

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

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

NCT01947907
(ClinicalTrials.gov)

July 2013

3/6/2013

Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

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)

Drug: ACP-001;Drug: Human Growth Hormone

Ascendis Pharma A/S

NULL

Completed

3 Years

12 Years

All

Phase 2

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

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-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

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

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

EUCTR2012-002787-27-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

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

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

EUCTR2010-020742-10-GB
(EUCTR)

09/05/2011

04/11/2010

Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.

Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin

Ipsen Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Spain;Sweden

EUCTR2010-020742-10-ES
(EUCTR)

01/04/2011

07/01/2011

Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica

Niños pre-puberales con déficit idiopático de hormona de crecimiento
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable
INN or Proposed INN: SOMATROPINA
Other descriptive name: SOMATROPIN
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA

Ipsen Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Finland;United Kingdom;Spain;Sweden

EUCTR2010-020742-10-SE
(EUCTR)

23/02/2011

19/11/2010

Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].

Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin

Ipsen Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Spain;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

EUCTR2010-019374-32-AT
(EUCTR)

15/02/2011

29/12/2010

A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)

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

Product Name: n/a
Product Code: MOD-4023
Trade Name: Only medicinal products registered in Austria will be used in this clinical trial.
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone

ModigeneTech Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany

EUCTR2010-020742-10-FI
(EUCTR)

10/01/2011

22/11/2010

Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].

Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin

Ipsen Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Spain;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

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

EUCTR2010-019374-32-CZ
(EUCTR)

06/09/2010

15/06/2010

A study with MOD-4023 in patients with lack of Growth Hormone in the body

A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)

Growth Hormone Deficiency
MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Product Name: n/a
Product Code: MOD-4023
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone

Prolor Biotech Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel

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-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

NCT01605331
(ClinicalTrials.gov)

December 2009

22/5/2012

Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Growth Hormone Deficiency

Drug: sustained-release recombinant human GH (SR-rhGH)

LG Life Sciences

NULL

Completed

20 Years

N/A

Both

132

Phase 4

NULL

NCT00684957
(ClinicalTrials.gov)

January 2008

23/5/2008

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency

Growth Hormone Deficiency

Drug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1

Columbia University

Tercica

Terminated

25 Years

65 Years

Male

N/A

United States

EUCTR2006-002278-24-SE
(EUCTR)

15/05/2007

05/03/2007

A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden

EUCTR2006-002278-24-SK
(EUCTR)

20/04/2007

22/03/2007

A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

LG Life Sciences Ltd.

BioPartners GmbH

Not Recruiting

Female: yes
Male: yes

150

Phase 3

France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden

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

EUCTR2006-002278-24-FR
(EUCTR)

13/04/2007

24/11/2006

A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden

EUCTR2006-002278-24-AT
(EUCTR)

05/01/2007

10/11/2006

A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

LG Life Sciences Ltd.

BioPartners GmbH

Not Recruiting

Female: yes
Male: yes

150

Phase 3

United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden

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

EUCTR2006-002278-24-CZ
(EUCTR)

14/12/2006

08/09/2006

A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden

EUCTR2006-002278-24-ES
(EUCTR)

13/12/2006

10/03/2010

Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden

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

EUCTR2006-002278-24-DE
(EUCTR)

06/10/2006

15/08/2006

A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden

EUCTR2005-000384-26-DE
(EUCTR)

20/12/2005

02/06/2006

A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

United Kingdom;Czech Republic;Germany;Spain;Sweden

EUCTR2005-000384-26-AT
(EUCTR)

10/11/2005

10/06/2005

A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.

growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

LG Life Science Ltd.

BioPartners

Not Recruiting

Female: yes
Male: yes

138

Phase 3

Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden

EUCTR2005-000384-26-SK
(EUCTR)

27/10/2005

19/09/2005

A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.

growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

138

Phase 3

Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden

EUCTR2005-000384-26-CZ
(EUCTR)

30/09/2005

08/08/2005

A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Germany;United Kingdom;Czech Republic;Spain;Sweden

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

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

EUCTR2005-000384-26-SE
(EUCTR)

13/09/2005

27/06/2005

A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.

Growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

BioPartners GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Germany;United Kingdom;Czech Republic;Spain;Sweden

EUCTR2005-000384-26-ES
(EUCTR)

22/08/2005

27/06/2005

A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento

growth hormone deficiency in adults
MedDRA version: 8.0;Level: PT;Classification code 10056438

Product Code: LB03002
INN or Proposed INN: somatropin
Other descriptive name: recombinant human growth hormone (rhGH)

LG Life Science Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

138

Phase 3

Germany;United Kingdom;Czech Republic;Spain;Sweden

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

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

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

NCT00458991
(ClinicalTrials.gov)

June 2001

9/4/2007

rhGH Therapy on Hepatic Drug Metabolism

Recombinant Human Growth Hormone Therapy and Drug Metabolism

Growth Hormone Deficiency, Dwarfism

Drug: Dextromethorphan and Caffeine

University of Louisville

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Completed

4 Years

14 Years

All

N/A

United States

NCT00497484
(ClinicalTrials.gov)

February 1995

5/7/2007

Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia)

Pseudohypoparathyroidism;Growth Hormone Deficiency, Dwarfism

Drug: recombinant human somatotropin

University of Milan

Eli Lilly and Company

Active, not recruiting

1 Year

18 Years

Both

N/A

Italy

EUCTR2010-019374-32-DE
(EUCTR)

07/12/2010

A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)

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

Product Name: n/a
Product Code: MOD-4023
Trade Name: Only medicinal products registered in Germany will be used in this clinical trial
Product Name: recombinant human Growth Hormone (rhGH)
INN or Proposed INN: somatropin
Other descriptive name: recombinant DNA-derived human growth hormone

ModigeneTech Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Slovakia;Germany;Slovenia

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

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]

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