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	NCT01806298 (ClinicalTrials.gov)	June 2013	5/3/2013	An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)	Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)	Adult Growth Hormone Deficiency	Drug: Saizen® solution for injection (referred as Saizen®)	Merck KGaA	NULL	Completed	18 Years	65 Years	All	78	Phase 4	Australia;Germany;Sweden;United Kingdom;Czech Republic
2	EUCTR2012-004263-47-CZ (EUCTR)	13/05/2013	05/03/2013	Exploration if Saizen marketed solution for injection induces an immunogenic reaction	Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency	Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	77	Phase 4	Czech Republic;Australia;Germany;United Kingdom;Sweden
3	EUCTR2012-004263-47-DE (EUCTR)	03/04/2013	25/02/2013	Exploration if Saizen marketed solution for injection induces an immunogenic reaction	Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency	Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	77	Phase 4	Czech Republic;Australia;Germany;United Kingdom;Sweden
4	EUCTR2012-004263-47-SE (EUCTR)	06/03/2013	14/01/2013	Exploration if Saizen marketed solution for injection induces an immunogenic reaction	Open-label, single-arm, phase IV, multicenter trial to explore theimmunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD)	Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Trade Name: SAIZEN	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	77	Phase 4	Czech Republic;Australia;Germany;United Kingdom;Sweden
5	EUCTR2012-004263-47-GB (EUCTR)	01/03/2013	08/01/2013	Exploration if Saizen marketed solution for injection induces an immunogenic reaction	Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset - Saizen, Phase 4 study in Growth Hormone Deficiency	Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]		Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	77	Phase 4	Czech Republic;Australia;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
6	NCT01494779 (ClinicalTrials.gov)	March 2013	28/11/2011	Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.		GH Deficiency (GHD);Growth Retardation	Drug: Somatropin	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.	NULL	Not yet recruiting	18 Years	32 Years	Male	32	Phase 1	Brazil
7	NCT01237340 (ClinicalTrials.gov)	October 2010	5/11/2010	Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study	A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)	Growth Hormone Deficiency (GHD)	Drug: Saizen®	EMD Serono	NULL	Terminated	18 Years	60 Years	All	59	Phase 3	United States
8	NCT01187550 (ClinicalTrials.gov)	March 2007	22/8/2010	Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®	A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®	Dwarfism, Pituitary	Drug: Recombinant human growth hormone (r-hGH)	Merck KGaA	Merck Serono Co., Ltd., China	Completed	N/A	N/A	All	214	Phase 4	NULL
9	NCT00256126 (ClinicalTrials.gov)	May 31, 2005	18/11/2005	Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®	A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®	Growth Hormone Deficiency;Turner Syndrome	Drug: Saizen	Merck KGaA, Darmstadt, Germany	NULL	Completed	2 Years	16 Years	All	318	Phase 4	Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom
10	NCT00109733 (ClinicalTrials.gov)	January 2005	2/5/2005	Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency	A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS)	Childhood-onset Growth Hormone Deficiency;Pituitary Dwarfism	Biological: recombinant human growth hormone	EMD Serono	NULL	Completed	13 Years	25 Years	All	31	Phase 3	United States
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	NCT01157793 (ClinicalTrials.gov)	September 2003	6/7/2010	A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood	A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood	Dwarfism;Growth Hormone Deficiency	Drug: r-hGH	Merck KGaA	NULL	Completed	14 Years	25 Years	Both	34	Phase 4	NULL
12	EUCTR2015-001569-20-Outside-EU/EEA (EUCTR)		06/07/2015	Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®	A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®	Dwarfism, Pituitary MedDRA version: 18.0;Level: PT;Classification code 10013883;Term: Dwarfism;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Trade Name: Saizen	Merck Serono Co., Ltd.	NULL	NA			Female: yes Male: yes	214	Phase 4	China

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

NCT01806298
(ClinicalTrials.gov)

June 2013

5/3/2013

An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)

Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)

Adult Growth Hormone Deficiency

Drug: Saizen® solution for injection (referred as Saizen®)

Merck KGaA

NULL

Completed

18 Years

65 Years

All

Phase 4

Australia;Germany;Sweden;United Kingdom;Czech Republic

EUCTR2012-004263-47-CZ
(EUCTR)

13/05/2013

05/03/2013

Exploration if Saizen marketed solution for injection induces an immunogenic reaction

Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency

Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Trade Name: SAIZEN
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Australia;Germany;United Kingdom;Sweden

EUCTR2012-004263-47-DE
(EUCTR)

03/04/2013

25/02/2013

Exploration if Saizen marketed solution for injection induces an immunogenic reaction

Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency

Trade Name: SAIZEN
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Australia;Germany;United Kingdom;Sweden

EUCTR2012-004263-47-SE
(EUCTR)

06/03/2013

14/01/2013

Exploration if Saizen marketed solution for injection induces an immunogenic reaction

Open-label, single-arm, phase IV, multicenter trial to explore theimmunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD)

Trade Name: SAIZEN

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Australia;Germany;United Kingdom;Sweden

EUCTR2012-004263-47-GB
(EUCTR)

01/03/2013

08/01/2013

Exploration if Saizen marketed solution for injection induces an immunogenic reaction

Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset - Saizen, Phase 4 study in Growth Hormone Deficiency

Adult Growth Hormone Deficiency
MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Australia;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

NCT01494779
(ClinicalTrials.gov)

March 2013

28/11/2011

Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.

GH Deficiency (GHD);Growth Retardation

Drug: Somatropin

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

NULL

Not yet recruiting

18 Years

32 Years

Male

Phase 1

Brazil

NCT01237340
(ClinicalTrials.gov)

October 2010

5/11/2010

Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study

A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)

Growth Hormone Deficiency (GHD)

Drug: Saizen®

EMD Serono

NULL

Terminated

18 Years

60 Years

All

Phase 3

United States

NCT01187550
(ClinicalTrials.gov)

March 2007

22/8/2010

Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®

A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®

Dwarfism, Pituitary

Drug: Recombinant human growth hormone (r-hGH)

Merck KGaA

Merck Serono Co., Ltd., China

Completed

N/A

All

214

Phase 4

NULL

NCT00256126
(ClinicalTrials.gov)

May 31, 2005

18/11/2005

Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®

Growth Hormone Deficiency;Turner Syndrome

Drug: Saizen

Merck KGaA, Darmstadt, Germany

NULL

Completed

2 Years

16 Years

All

318

Phase 4

Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom

NCT00109733
(ClinicalTrials.gov)

January 2005

2/5/2005

Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency

A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS)

Childhood-onset Growth Hormone Deficiency;Pituitary Dwarfism

Biological: recombinant human growth hormone

EMD Serono

NULL

Completed

13 Years

25 Years

All

Phase 3

United States

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

NCT01157793
(ClinicalTrials.gov)

September 2003

6/7/2010

A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood

A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood

Dwarfism;Growth Hormone Deficiency

Drug: r-hGH

Merck KGaA

NULL

Completed

14 Years

25 Years

Both

Phase 4

NULL

EUCTR2015-001569-20-Outside-EU/EEA
(EUCTR)

06/07/2015

Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®

A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®

Dwarfism, Pituitary
MedDRA version: 18.0;Level: PT;Classification code 10013883;Term: Dwarfism;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Trade Name: Saizen

Merck Serono Co., Ltd.

NULL

Female: yes
Male: yes

214

Phase 4

China