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	JPRN-JapicCTI-183963	25/12/2017	17/05/2018	Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency	A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY	Treatment of children with growth failure due to growth hormone deficiency (GHD)	Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day).	OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd)	NULL	complete	3	11	BOTH	44	Phase 3	Japan

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

JPRN-JapicCTI-183963

25/12/2017

17/05/2018

Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY

Treatment of children with growth failure due to growth hormone deficiency (GHD)

Intervention name : Somatrogon (Genetical Recombination)
INN of the intervention : somatrogon
Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
Control intervention name : Genotropin
INN of the control intervention : somatropin
Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day).

OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd)

NULL

complete

BOTH

Phase 3

Japan