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	NCT03878953 (ClinicalTrials.gov)	March 31, 2021	15/3/2019	A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism	A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism	Chronic Hypoparathyroidism	Drug: rhPTH (1-84)	Shire	NULL	Not yet recruiting	20 Years	85 Years	All	12	Phase 3	Japan
2	NCT03364738 (ClinicalTrials.gov)	September 26, 2018	20/11/2017	Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism	An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With Hypoparathyroidism	Hypoparathyroidism	Biological: rhPTH (1-84)	Shire	NULL	Completed	18 Years	N/A	All	22	Phase 3	United States;Canada;Denmark;Hungary
3	EUCTR2017-003067-36-DK (EUCTR)	08/08/2018	08/06/2018	A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.	An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.	Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]	Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 3	Denmark;United States;Hungary;Canada
4	EUCTR2017-003067-36-HU (EUCTR)	28/06/2018	25/04/2018	A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.	An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.	Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]	Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH (1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	32	Phase 3	United States;Hungary;Canada;Denmark
5	EUCTR2017-000284-32-PT (EUCTR)	02/04/2018	16/11/2017	Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]	A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]	Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]	Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3;Phase 4	France;United States;Portugal;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;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	NCT03324880 (ClinicalTrials.gov)	February 15, 2018	10/10/2017	Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With Hypoparathyroidism	A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]	Hypoparathyroidism	Biological: rhPTH (1-84);Biological: Placebo	Shire	NULL	Recruiting	18 Years	85 Years	All	150	Phase 4	United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
7	EUCTR2017-000284-32-SE (EUCTR)	18/01/2018	02/11/2017	Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]	A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]	Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]	Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84)	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3;Phase 4	Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
8	EUCTR2017-000284-32-DK (EUCTR)	10/01/2018	09/11/2017	Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]	A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]	Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]	Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH (1-84)	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3;Phase 4	Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
9	NCT03150108 (ClinicalTrials.gov)	May 16, 2017	1/5/2017	Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects	A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese Subjects	Hypoparathyroidism	Drug: rhPTH (1-84)	Shire	NULL	Completed	18 Years	65 Years	All	24	Phase 1	United States
10	NCT02781844 (ClinicalTrials.gov)	April 3, 2017	19/4/2016	Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism	An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism	Hypoparathyroidism	Drug: 25mcg rhPTH(1-84);Drug: 50mcg rhPTH(1-84);Drug: 100mcg rhPTH(1-84)	Shire	NULL	Completed	18 Years	N/A	All	34	Phase 1	United States;Canada;Denmark;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
11	NCT02910466 (ClinicalTrials.gov)	December 9, 2016	20/9/2016	A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism	A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism	Chronic Hypoparathyroidism;Hypoparathyroidism	Drug: rhPTH (1-84)	Shire	NULL	Completed	18 Years	85 Years	All	36	Phase 4	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

NCT03878953
(ClinicalTrials.gov)

March 31, 2021

15/3/2019

A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism

A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism

Chronic Hypoparathyroidism

Drug: rhPTH (1-84)

Shire

NULL

Not yet recruiting

20 Years

85 Years

All

Phase 3

Japan

NCT03364738
(ClinicalTrials.gov)

September 26, 2018

20/11/2017

Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism

An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With Hypoparathyroidism

Hypoparathyroidism

Biological: rhPTH (1-84)

Shire

NULL

Completed

18 Years

N/A

All

Phase 3

United States;Canada;Denmark;Hungary

EUCTR2017-003067-36-DK
(EUCTR)

08/08/2018

08/06/2018

A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.

An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.

Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]

Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Denmark;United States;Hungary;Canada

EUCTR2017-003067-36-HU
(EUCTR)

28/06/2018

25/04/2018

A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.

An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Hungary;Canada;Denmark

EUCTR2017-000284-32-PT
(EUCTR)

02/04/2018

16/11/2017

Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]

A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]

Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3;Phase 4

France;United States;Portugal;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;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

NCT03324880
(ClinicalTrials.gov)

February 15, 2018

10/10/2017

Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With Hypoparathyroidism

Hypoparathyroidism

Biological: rhPTH (1-84);Biological: Placebo

Shire

NULL

Recruiting

18 Years

85 Years

All

150

Phase 4

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

EUCTR2017-000284-32-SE
(EUCTR)

18/01/2018

02/11/2017

Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]

Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH (1-84)

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3;Phase 4

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

EUCTR2017-000284-32-DK
(EUCTR)

10/01/2018

09/11/2017

Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3;Phase 4

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

NCT03150108
(ClinicalTrials.gov)

May 16, 2017

1/5/2017

Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects

A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese Subjects

Hypoparathyroidism

Drug: rhPTH (1-84)

Shire

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

NCT02781844
(ClinicalTrials.gov)

April 3, 2017

19/4/2016

Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism

An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism

Hypoparathyroidism

Drug: 25mcg rhPTH(1-84);Drug: 50mcg rhPTH(1-84);Drug: 100mcg rhPTH(1-84)

Shire

NULL

Completed

18 Years

N/A

All

Phase 1

United States;Canada;Denmark;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

NCT02910466
(ClinicalTrials.gov)

December 9, 2016

20/9/2016

A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism

Chronic Hypoparathyroidism;Hypoparathyroidism

Drug: rhPTH (1-84)

Shire

NULL

Completed

18 Years

85 Years

All

Phase 4

United States