DDrare: Database of Drug Development for Rare Diseases

Searched query = "Hypoparathyroidism", "Accessory thyroid hypergasia disease"
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 = 100mcg rhPTH(1-84); 25mcg rhPTH(1-84); 50mcg rhPTH(1-84); A: PTH (1-84); Acetate; Alfacalcidol; Amorphous calcium carbonate; Betamethasone; CLTX-305; Calcitriol; Calcitriol & Calcium; Calcium; Calcium Carbonate; Calcium Citrate; Calcium carbonate; Calcium carbonate and alphacalcidol; Calcium citrate; Calcium gluconate; Calcium lactate; Carbonate; Combination Product: TransCon PTH; Combination product (Natpara) and drug or supplements [Disease and drug registry]; Crystalline calcium supplements; Dexamethasone; Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland).; Diagnostic Test: Postoperative laboratory blood tests at 24 hour; Diagnostic Test: Postoperative laboratory blood tests at 6 hour; Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour; Diagnostic Test: Preoparative blood laboratory tests; EB612 (EBP05); ESIDREX-R; ESIDREX-R 25 mg; EnteraBio's Oral Parathyroid Hormone (1-34); Esidrex; Ether; FORSTEO; FORSTEO-R; Forsteo; Human recombinant parathyroid Hormone; Human recombinant parathyroid hormone; Hydrochlorothiazide; INDOCYANINE GREEN; INN Parathyroid Hormone (1-84) human; Immediate post operative bioassay of Parathyroid Hormone; Indocyanine Green; Indocyanine green; Magnesium; NATPARA/NATPAR; NPSP 558; NPSP558; Natpar; Natpara; Open-label PTH(1-84); Other: Empiric use of Calcium Carbonate and Calcitriol; Other: PTH based Calcium Carbonate and Calcitriol repletion; Other: Postoperative nausea and vomiting at 24 hour; Other: Postoperative nausea and vomiting at 6 hour; Other: Postoperative pain at 24 hour; Other: Postoperative pain at 6 hour; Other: Postoperative sore throat and hoarseness at 24 hour; Other: Postoperative sore throat and hoarseness at 6 hour; Other: Serum calcium concentrations results; Other: Symptomatic hypocalcaemia at 24 hour; Other: Symptomatic hypocalcaemia at 6 hour; PARATHYROID HORMONE; PCO371; POLY(OXY-1,2-ETHANEDIYL), A; POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1); PREOTACT; PTH; PTH 1-34; PTH1-84 in parent study; Parathyroid; Parathyroid Hormone; Parathyroid Hormone (1-84) Human Recombinant; Parathyroid Hormone (rDNA); Parathyroid hormon 1-84; Parathyroid hormone; Parathyroid hormone (rdna); Parathyroideahormon; Phosphate; Phosphate and betamethasone acetate, 2 mL.; Polyethylene glycol; Potassium; Potassium sparing diuretic; Preotact; Procedure: Total thyroidectomy; RECOMBINANT HUMAN PARATHYROID HORMONE (1-84); Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]; Recombinant Human Parathyroid Hormone [rhPTH(1-84)]; RhPTH; RhPTH (1-84); RhPTH(1-84); SUB21634; Saline 0.9% NaCl; Sevelamer; Sodium citrate; Synthetic Human Parathyroid Hormone 1-34; TERIPARATIDE; Teriparatide; Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker; Thiazide; Thymus/Parathyroid Transplantation; TransCon PTH; TransCon PTH high-dose pen; TransCon PTH low-dose pen; TransCon PTH mid-dose pen; Tériparatide; UN-ALPHA-R; UN-ALPHA-R 0.25µg; Verde de Indocianina (Indocyanine Green); Vitamin D

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	NCT01455181 (ClinicalTrials.gov)	August 19, 2011	15/9/2011	A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary	A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study	Hypoparathyroidism	Drug: NPSP558	Shire	NULL	Completed	18 Years	85 Years	All	24	Phase 3	Hungary
2	EUCTR2011-001265-40-HU (EUCTR)	29/07/2011	23/05/2011	A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with Hypoparathyroidism	A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults with Hypoparathyroidism - A Clinical Extension Study - Not applicable	Hypoparathyroidism MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE	NPS Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	30		Hungary
3	NCT01297309 (ClinicalTrials.gov)	April 6, 2011	11/2/2011	A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)	A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)	Hypoparathyroidism	Drug: NPSP558	Shire	NULL	Completed	18 Years	85 Years	All	51	Phase 3	United States
4	NCT01268098 (ClinicalTrials.gov)	January 2011	28/12/2010	Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)	A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism	Hypoparathyroidism	Drug: NPSP558	Shire	NULL	Completed	18 Years	85 Years	All	42	Phase 3	United States
5	EUCTR2008-005063-34-IT (EUCTR)	27/04/2009	18/06/2009	A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040	A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040	Hypoparatthyroidism MedDRA version: 12.0;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism	Product Code: NPSP 558 Product Code: NPSP 558 Product Code: NPSP 558	NPS PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	84	Phase 3	Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
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	NCT00732615 (ClinicalTrials.gov)	December 2008	8/8/2008	Use of NPSP558 in the Treatment of Hypoparathyroidism	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism	Hypoparathyroidism	Drug: Placebo;Drug: NPSP558	Shire	NULL	Completed	18 Years	85 Years	All	124	Phase 3	United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom

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

NCT01455181
(ClinicalTrials.gov)

August 19, 2011

15/9/2011

A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study

Hypoparathyroidism

Drug: NPSP558

Shire

NULL

Completed

18 Years

85 Years

All

Phase 3

Hungary

EUCTR2011-001265-40-HU
(EUCTR)

29/07/2011

23/05/2011

A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with Hypoparathyroidism

A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults with Hypoparathyroidism - A Clinical Extension Study - Not applicable

Hypoparathyroidism
MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE

NPS Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary

NCT01297309
(ClinicalTrials.gov)

April 6, 2011

11/2/2011

A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Hypoparathyroidism

Drug: NPSP558

Shire

NULL

Completed

18 Years

85 Years

All

Phase 3

United States

NCT01268098
(ClinicalTrials.gov)

January 2011

28/12/2010

Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism

Hypoparathyroidism

Drug: NPSP558

Shire

NULL

Completed

18 Years

85 Years

All

Phase 3

United States

EUCTR2008-005063-34-IT
(EUCTR)

27/04/2009

18/06/2009

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040

Hypoparatthyroidism
MedDRA version: 12.0;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism

Product Code: NPSP 558
Product Code: NPSP 558
Product Code: NPSP 558

NPS PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania

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

NCT00732615
(ClinicalTrials.gov)

December 2008

8/8/2008

Use of NPSP558 in the Treatment of Hypoparathyroidism

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

Hypoparathyroidism

Drug: Placebo;Drug: NPSP558

Shire

NULL

Completed

18 Years

85 Years

All

124

Phase 3

United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom