Parathyroid    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
235Hypoparathyroidism40

235. Hypoparathyroidism    [ 67 clinical trials,   112 drugs,   (DrugBank: 24 drugs),   4 drug target genes,   5 drug target pathways]
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.
40 / 67 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
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PhaseCountries
1JPRN-JapicCTI-194828
31/3/202125/06/2019A Clinical Study of rhPTH (1-84) Treatment in Japanese Participants With Chronic HypoparathyroidismA Phase 3, Open-label Clinical Study of rhPTH (1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism Chronic HypoparathyroidismIntervention name : rhPTH (1-84)
INN of the intervention : Parathyroid hormone
Dosage And administration of the intervention : rhPTH (1-84) will be administered at 25, 50, 75 and 100 micrograms once daily in one of the thighs (alternate thigh every day) as a subcutaneous injection.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLpending2085BOTH12Phase 3Japan
2EUCTR2019-003506-26-ES
(EUCTR)
05/03/202014/01/2020Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total ThyroidectomyDetermination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green to predict the possible occurrence of postoperative hypocalcemia
MedDRA version: 20.1;Level: LLT;Classification code 10020949;Term: Hypocalcemia;System Organ Class: 100000004861
MedDRA version: 20.0;Classification code 10043777;Term: Thyroidectomy total;System Organ Class: 100000004865
MedDRA version: 21.0;Level: PT;Classification code 10080819;Term: Post procedural hypoparathyroidism;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Verde de Indocianina (Indocyanine Green)
Product Name: Indocyanine Green
INN or Proposed INN: Indocyanine green
Other descriptive name: INDOCYANINE GREEN
Hospital Universitari Son EspasesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 4Spain
3NCT04009291
(ClinicalTrials.gov)
August 27, 201920/6/2019A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With HypoparathyroidismPaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With HypoparathyroidismHypoparathyroidism;Endocrine System Diseases;Parathyroid DiseasesCombination Product: TransCon PTH;Combination Product: Placebo for TransCon PTHAscendis Pharma A/SNULLActive, not recruiting18 YearsN/AAll40Phase 2United States;Canada;Denmark;Germany;Italy;Norway;United Kingdom
4ChiCTR1900022194
2019-04-022019-03-30A prospective randomized controlled trial of different calcium supplementation regimens on the recovery of parathyroid function after thyroid surgeryA prospective randomized controlled trial of different calcium supplementation regimens on the recovery of parathyroid function after thyroid surgery HypoparathyroidismProphylactic group:Prophylactic calcium and vitamin D supplementation;treatment group:calcium and vitamin Dsupplementation is appropriate for hypocalcemia symptomatic patients;West China Hospital, Sichuan UniversityNULLRecruiting1875BothProphylactic group:150;treatment group:150;N/AChina
5EUCTR2017-003067-36-DK
(EUCTR)
08/08/201808/06/2018A 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.NULLNot RecruitingFemale: yes
Male: yes
32Phase 3Denmark;United States;Hungary;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-003067-36-HU
(EUCTR)
28/06/201825/04/2018A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 3United States;Hungary;Canada;Denmark
7NCT03516773
(ClinicalTrials.gov)
June 17, 201823/4/2018Oral PTH(1-34) PK and PD Study in Patients With HypoparathyroidismAn Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Parathyroid Hormone [PTH (1-34)] and NATPARA® in Patients With HypoparathyroidismHypoparathyroidismDrug: EB612 (EBP05);Drug: NATPARA/NATPAREntera Bio Ltd.NULLCompleted18 Years80 YearsAll20Phase 2Israel
8EUCTR2017-000284-32-NL
(EUCTR)
04/06/201801/11/2017 Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3;Phase 4Portugal;France;United States;Belgium;Spain;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden
9EUCTR2017-000284-32-PT
(EUCTR)
02/04/201816/11/2017Symptom 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4France;United States;Portugal;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
10EUCTR2017-000284-32-BE
(EUCTR)
30/03/201818/12/2017 Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3;Phase 4Portugal;France;United States;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03324880
(ClinicalTrials.gov)
February 15, 201810/10/2017Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With HypoparathyroidismA 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)]HypoparathyroidismBiological: rhPTH(1-84);Biological: PlaceboShireNULLRecruiting18 Years85 YearsAll150Phase 4United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
12EUCTR2017-000284-32-GB
(EUCTR)
05/02/201827/10/2017 Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3;Phase 4United States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
13EUCTR2017-000284-32-SE
(EUCTR)
18/01/201802/11/2017Symptom 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
14EUCTR2017-000284-32-DK
(EUCTR)
10/01/201809/11/2017Symptom 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
15NCT02781844
(ClinicalTrials.gov)
April 3, 201719/4/2016Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With HypoparathyroidismAn 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 HypoparathyroidismHypoparathyroidismDrug: 25mcg rhPTH(1-84);Drug: 50mcg rhPTH(1-84);Drug: 100mcg rhPTH(1-84)ShireNULLCompleted18 YearsN/AAll34Phase 1United States;Canada;Denmark;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02910466
(ClinicalTrials.gov)
December 9, 201620/9/2016A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in HypoparathyroidismA Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in HypoparathyroidismChronic Hypoparathyroidism;HypoparathyroidismDrug: rhPTH(1-84)ShireNULLCompleted18 Years85 YearsAll36Phase 4United States
17NCT04012476
(ClinicalTrials.gov)
November 201628/6/2019Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total ThyroidectomyDetermination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total ThyroidectomyHypocalcemia;Total Thyroidectomy;Hypoparathyroidism PostproceduralDrug: Indocyanine GreenHospital Son EspasesUniversitat de les Illes BalearsRecruiting18 YearsN/AAll40Phase 4Spain
18NCT02986607
(ClinicalTrials.gov)
March 20165/12/2016Corticosteroid Rhythms in Hypoparathyroid PatientsCorticosteroid Rhythms in Hypoparathyroid PatientsHypoparathyroidism;HyperparathyroidismDrug: parathyroid hormon 1-84University of BergenHaukeland University HospitalRecruiting18 Years60 YearsAll30Early Phase 1Norway
19EUCTR2015-003108-22-GB
(EUCTR)
08/12/201526/10/2015Study on parathyroid hormone for use in hypoparathyroidism in children 12 to less than 18 years old.An Open-label, Single-dose Study to Determine the Pharmacokinetic/Pharmacodynamic Profile of Parathyroid Hormone (rDNA) Administered Subcutaneously at a Dose of50 µg in Subjects with Hypoparathyroidism Who Are 12 to LessThan 18 Years of Age Chronic hypoparathyroidism;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Parathyroid Hormone (rDNA)
Product Code: NPSP 558
INN or Proposed INN: INN Parathyroid Hormone (1-84) human
Other descriptive name: Parathyroid Hormone (1-84) Human Recombinant
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
10Phase 1United Kingdom
20NCT02152228
(ClinicalTrials.gov)
July 201422/4/2014A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of HypoparathyroidismA Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of HypoparathyroidismHypoparathyroidismDrug: EnteraBio's Oral Parathyroid Hormone (1-34)Entera Bio Ltd.NULLCompleted18 Years80 YearsBoth20Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-001890-26-IT
(EUCTR)
06/05/201427/03/2014Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidismRecombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism Refractory hypoparathyroidism
MedDRA version: 16.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: FORSTEO
Product Name: FORSTEO
INN or Proposed INN: TERIPARATIDE
Dipartimento di Medicina e Chirurgia Traslazionale dell’Università degli Studi di FirenzeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Italy
22NCT02924532
(ClinicalTrials.gov)
February 201213/9/2016Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total ThyroidectomyDiagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational StudyHypoparathyroidismBiological: immediate post operative bioassay of Parathyroid HormoneCentre Hospitalier Universitaire de NimesNULLCompleted18 YearsN/ABoth300N/ANULL
23NCT01455181
(ClinicalTrials.gov)
August 19, 201115/9/2011A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in HungaryA 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 StudyHypoparathyroidismDrug: NPSP558ShireNULLCompleted18 Years85 YearsAll24Phase 3Hungary
24EUCTR2011-001265-40-HU
(EUCTR)
29/07/201123/05/2011A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with HypoparathyroidismA 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.NULLNot RecruitingFemale: yes
Male: yes
30Hungary
25NCT01297309
(ClinicalTrials.gov)
April 6, 201111/2/2011A 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)HypoparathyroidismDrug: NPSP558ShireNULLCompleted18 Years85 YearsAll51Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01268098
(ClinicalTrials.gov)
January 201128/12/2010Study 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 HypoparathyroidismHypoparathyroidismDrug: NPSP558ShireNULLCompleted18 Years85 YearsAll42Phase 3United States
27EUCTR2008-005063-34-LT
(EUCTR)
29/11/201016/08/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.0;Level: PT;Classification code 10021041;Term:
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: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
28EUCTR2008-005063-34-HU
(EUCTR)
27/09/201004/10/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
110Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
29NCT00856401
(ClinicalTrials.gov)
September 20104/3/2009ADD-ON Study to Existing Hypoparathyroidism StudiesPhase II Trial of Parathyroid Hormone for the Treatment of HypoparathyroidismHypoparathyroidismDrug: PTH1-84 in parent studyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLActive, not recruiting18 Years85 YearsAll62Phase 3United States
30EUCTR2008-005063-34-FR
(EUCTR)
14/09/200914/11/2008A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 9.1;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2008-005063-34-DK
(EUCTR)
27/08/200917/11/2008A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.0;Level: PT;Classification code 10021041;Term:
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
110Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
32EUCTR2008-005063-34-GB
(EUCTR)
04/08/200922/05/2009A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.0;Level: PT;Classification code 10021041;Term:
NPS Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
110Phase 3France;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom
33EUCTR2008-005063-34-IT
(EUCTR)
27/04/200918/06/2009A 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 - CL1-11-040A 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
34NCT00732615
(ClinicalTrials.gov)
December 20088/8/2008Use of NPSP558 in the Treatment of HypoparathyroidismA 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 HypoparathyroidismHypoparathyroidismDrug: Placebo;Drug: NPSP558ShireNULLCompleted18 Years85 YearsAll124Phase 3United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom
35EUCTR2008-005063-34-BE
(EUCTR)
18/11/200818/11/2008A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 12.0;Level: PT;Classification code 10021041;Term:
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Lithuania;Denmark;Italy;United Kingdom;France;Hungary;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00743782
(ClinicalTrials.gov)
August 22, 200828/8/2008Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic HypoparathyroidismComparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic HypoparathyroidismHypoparathyroidism;HypocalcemiaDrug: Synthetic Human Parathyroid Hormone 1-34Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted7 Years70 YearsAll24Early Phase 1United States
37EUCTR2008-000606-36-DK
(EUCTR)
07/04/200825/03/2008Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPTTreatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT Hypoparathyroidism
MedDRA version: 9.1;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism
Trade Name: Preotact
Product Name: parathyroid hormone (rdna)
Product Code: SUB21634
INN or Proposed INN: Parathyroideahormon
Aarhus University Hospital, Dept of Endocrinology and Metabolism CNULLNot RecruitingFemale: yes
Male: yes
60Denmark
38NCT00566488
(ClinicalTrials.gov)
January 200530/11/2007Parathyroid and Thymus Transplantation in DiGeorge #931Parathyroid and Thymus Transplantation in DiGeorge Syndrome, #931DiGeorge Syndrome;Hypoparathyroidism;Complete DiGeorge SyndromeBiological: Thymus/Parathyroid TransplantationM. Louise MarkertFood and Drug Administration (FDA);National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);Enzyvant Therapeutics GmbHCompletedN/A24 MonthsAll25Phase 1United States
39NCT00004361
(ClinicalTrials.gov)
July 199518/10/1999Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac DefectsHypoparathyroidism;Tetralogy of Fallot;Pulmonary Valve Stenosis;Conotruncal Cardiac Defects;Heart Defects, Congenital;Pulmonary AtresiaDrug: calcium gluconate;Drug: sodium citrateNational Center for Research Resources (NCRR)Ann & Robert H Lurie Children's Hospital of ChicagoCompleted18 YearsN/ABoth150N/ANULL
40NCT00001304
(ClinicalTrials.gov)
October 19913/11/1999Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34HypoparathyroidismDrug: Synthetic Human Parathyroid Hormone 1-34;Drug: Calcitriol & CalciumEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted17 Years69 YearsAll27Phase 2United States