DDrare: Database of Drug Development for Rare Diseases

78. 下垂体前葉機能低下症
［臨床試験数：462，薬物数：346（DrugBank：45），標的遺伝子数：41，標的パスウェイ数：80］

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	EUCTR2007-001746-40-HU (EUCTR)	25/08/2008	02/04/2007	A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD)	A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD)	Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency	Product Code: ARX201 Other descriptive name: Pegylated recombinant human growth hormone	Ambrx, Inc., USA	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2b	Hungary
2	NCT00778518 (ClinicalTrials.gov)	July 2008	22/10/2008	Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).	Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).	Growth Hormone Deficiency	Drug: ARX201	Ambrx, Inc.	Merck Serono International SA	Completed	18 Years	30 Years	Male	36	Phase 2	Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-001746-40-HU
(EUCTR)

25/08/2008

02/04/2007

A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD)

Growth Hormone Deficiency
MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency

Product Code: ARX201
Other descriptive name: Pegylated recombinant human growth hormone

Ambrx, Inc., USA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2b

Hungary

NCT00778518
(ClinicalTrials.gov)

July 2008

22/10/2008

Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Growth Hormone Deficiency

Drug: ARX201

Ambrx, Inc.

Merck Serono International SA

Completed

18 Years

30 Years

Male

Phase 2

Hungary