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 235. 副甲状腺機能低下症 [臨床試験数:44,薬物数:59(DrugBank:18),標的遺伝子数:4,標的パスウェイ数:4] 

Searched query = "Hypoparathyroidism", "Accessory thyroid hypergasia disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
Inclusion_
agemin
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PhaseCountries
1NCT03878953March 30, 20204 November 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 HypoparathyroidismChronic HypoparathyroidismDrug: rhPTH(1-84)ShireNot recruiting20 Years85 YearsAll12Phase 3Japan
2NCT03425747September 1, 201926 August 2019Efficacy of Calcium Citrate Versus Calcium Carbonate in Maintaining Normal Serum Calcium Level and Changing Quality of Life in Patients With Chronic HypoparathyroidismCALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISMChronic HypoparathyroidismDrug: Calcium Carbonate;Drug: Calcium CitrateCampus Bio-Medico UniversityNot recruiting18 Years75 YearsAll22Phase 4
3NCT04126941June 1, 201928 October 2019Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdismBi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center ExperienceHypoparathyroidismOther: Serum calcium concentrations resultsHospices Civils de LyonRecruiting2 Years18 YearsAll9N/AFrance
4ChiCTR19000221942019-04-021 April 2019A 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 surgeryHypoparathyroidismProphylactic group:Prophylactic calcium and vitamin D supplementation;treatment group:calcium and vitamin Dsupplementation is appropriate for hypocalcemia symptomatic patients;West China Hospital, Sichuan UniversityRecruiting1875BothProphylactic group:150;treatment group:150;N/AChina
5NCT03364738September 26, 201811 June 2019Safety and Efficacy Study of rhPTH(1-84) in Subjects With HypoparathyroidismAn Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With HypoparathyroidismHypoparathyroidismBiological: rhPTH(1-84)ShireNot recruiting18 YearsN/AAll22Phase 3United States;Canada;Denmark;Hungary
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
6NCT03516773June 17, 20188 April 2019Oral 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.Not recruiting18 Years80 YearsAll20Phase 2Israel
7NCT03324880February 15, 201823 April 2019Study 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: PlaceboShireRecruiting18 Years85 YearsAll150Phase 4United States;Belgium;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
8EUCTR2017-000284-32-SE18/01/201828 February 2019Symptom 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 Level: PT Classification code 10075900 Term: Primary hypoparathyroidism System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0 Level: PT 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)
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
CAS Number: 9002-64-6
Current Sponsor code: SHP634
Other descriptive name: Parathyroid Hormone
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Lyophilisate and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
CAS Number: 9002-64-6
Current Sponsor code: SHP634
Other descriptive name: Parathyroid Hormone
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Lyophilisate and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
CAS Number: 9002-64-6
Current Sponsor code: SHP634
Shire Human Genetic Therapies, Inc.Authorised Female: yes
Male: yes
150Phase 3;Phase 4Portugal;France;United States;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
9EUCTR2017-000284-32-DK10/01/201828 February 2019Symptom 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 Level: PT Classification code 10075900 Term: Primary hypoparathyroidism System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0 Level: PT 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)
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
CAS Number: 9002-64-6
Current Sponsor code: SHP634
Other descriptive name: Parathyroid Hormone
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Lyophilisate and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
CAS Number: 9002-64-6
Current Sponsor code: SHP634
Other descriptive name: Parathyroid Hormone
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Lyophilisate and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
CAS Number: 9002-64-6
Current Sponsor code: SHP634
Shire Human Genetic Therapies, Inc.Authorised Female: yes
Male: yes
150Phase 3;Phase 4Portugal;France;United States;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
10NCT03249012September 1, 201711 February 2019Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy HypoparathyroidismComparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy HypoparathyroidismHypoparathyroidism Postprocedural;Quality of LifeOther: Empiric use of Calcium Carbonate and Calcitriol;Other: PTH based Calcium Carbonate and Calcitriol repletionCHU de Quebec-Universite LavalRecruiting18 YearsN/AAll120N/ACanada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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Target_
size
PhaseCountries
11NCT02824718June 6, 20177 October 2019Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary HypoparathyroidismA Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary HypoparathyroidismAutosomal Dominant Hypocalcemia or OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under TreatmentDrug: Teriparatide;Drug: Thiazide;Drug: Potassium sparing diuretic;Drug: AlfacalcidolAssistance Publique - Hôpitaux de ParisMinistry of Health, FranceRecruiting18 Years80 YearsAll12Phase 2France
12NCT03150108May 16, 201716 December 2017Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult SubjectsA 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 SubjectsHypoparathyroidismDrug: rhPTH(1-84)ShireNot recruiting18 Years65 YearsAll24Phase 1United States
13NCT02781844March 11, 20178 April 2019Study 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)ShireNot recruiting18 YearsN/AAll33Phase 1United States;Canada;Denmark;Hungary
14NCT04146259January 1, 201711 November 2019Changes in Circulating Sclerostin Levels During Acute Postsurgical HypoparathyroidismChanges in Circulating Sclerostin Levels During Acute Postsurgical HypoparathyroidismHypoparathyroidism PostproceduralDrug: calcium carbonate and alphacalcidolUniversity of AthensNot recruiting19 YearsN/AFemale109Phase 4Greece
15NCT02910466December 9, 201620 May 2019A 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)ShireNot recruiting18 Years85 YearsAll50Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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size
PhaseCountries
16NCT04012476November 201622 July 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
17NCT02986607March 201616 December 2017Corticosteroid Rhythms in Hypoparathyroid PatientsCorticosteroid Rhythms in Hypoparathyroid PatientsHypoparathyroidism;HyperparathyroidismDrug: parathyroid hormon 1-84University of BergenHaukeland University HospitalRecruiting18 Years60 YearsAll30Early Phase 1Norway
18NCT02652884January 201618 April 2016Steroids in the Postoperative Transient Hypoparathyroidism Total ThyroidectomyEvaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total ThyroidectomyTransient HypoparathyroidismDrug: phosphate and betamethasone acetate, 2 mL.;Drug: saline 0.9% NaClHospital Italiano de Buenos AiresRecruiting18 YearsN/ABoth110Phase 4Argentina
19EUCTR2015-003108-22-GB08/12/201525 April 2016Study 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 of 50 µg in Subjects with Hypoparathyroidism Who Are 12 to Less Than 18 Years of AgeChronic hypoparathyroidism;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Parathyroid Hormone (rDNA)
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INN Parathyroid Hormone (1-84) human
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: Parathyroid Hormone (1-84) Human Recombinant
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
NPS Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
10United Kingdom
20NCT02152228July 201419 October 2015A 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.Not recruiting18 Years80 YearsBoth20Phase 2Israel
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-001890-26-IT06/05/201426 February 2018Recombinant 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 hypoparathyroidismRefractory 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: TERIPARATIDE
CAS Number: 52232-67-4
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: range
Concentration number: 20-40
Dipartimento di Medicina e Chirurgia Traslazionale dell’Università degli Studi di FirenzeAuthorisedFemale: yes
Male: yes
30Phase 3Italy
22NCT01922440July 1, 201315 July 2019A Registry for Patients With Chronic HypoparathyroidismPARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic HypoparathyroidismChronic HypoparathyroidismDrug: Combination product (Natpara) and drug or supplements [Disease and drug registry]ShireRecruitingN/AN/AAll900Phase 1United States;Austria;Canada;Denmark;Germany;Norway;Sweden
23NCT01815021April 201313 April 2015A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism PatientsA Randomized, Two Phase, Adaptive Then Crossover Open-label, Study Comparing Amorphous Calcium Carbonate (ACC) Supplement Versus Commercially Available Crystalline Calcium Supplements (CCS) in the Management of Primary Hypoparathyroidism.HypoparathyroidismDietary Supplement: amorphous calcium carbonate;Dietary Supplement: crystalline calcium supplementsAmorphical Ltd.Not recruiting18 Years80 YearsBoth10Phase 1/Phase 2Israel
24NCT02924532February 201217 October 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 NimesNot recruiting18 YearsN/ABoth300N/A
25NCT01455181August 201119 October 2017A 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: NPSP558ShireNot recruiting18 Years85 YearsAll24Phase 3Hungary
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-001265-40-HU29/07/201112 November 2012A 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 applicableHypoparathyroidism
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
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: PARATHYROID HORMONE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: PARATHYROID HORMONE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: PARATHYROID HORMONE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
NPS Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
30Hungary
27NCT01297309April 1, 201127 August 2018A 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: NPSP558ShireNot recruiting18 Years85 YearsAll53Phase 3United States
28NCT01268098January 201119 October 2017Study 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: NPSP558ShireNot recruiting18 Years85 YearsAll42Phase 3United States
29NCT01171690November 201019 October 2017Teriparatide for Postsurgical HypoparathyroidismPilot Study of Teriparatide for Postsurgical HypoparathyroidismHypoparathyroidism Post-surgicalDrug: TeriparatideMayo ClinicNot recruiting18 Years80 YearsAll5Phase 2United States
30NCT00856401September 201012 March 2018ADD-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)Not recruiting18 Years85 YearsAll62Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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sponsor
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agemin
Inclusion_
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size
PhaseCountries
31NCT01199614December 200920 August 2018HEXT (Hypo EXTended): Effect of PTH on Skeleton in HypoparathyroidismHEXT: The Hypoparathyroidism Studies, EXTended: The Effect of PTH on the Skeleton in HypoparathyroidismHypoparathyroidismDrug: open-label PTH(1-84)John P. BilezikianNPS Pharma;ShireNot recruiting18 Years85 YearsAll75Phase 3United States
32EUCTR2008-005063-34-FR14/09/200928 August 2012A 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 applicableHypoparathyroidism
MedDRA version: 9.1 Level: LLT Classification code 10021041 Term: Hypoparathyroidism
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: PARATHYROID HORMONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.61-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: PARATHYROID HORMONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.20-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: NPSP 558
Other descriptive name: PARATHYROID HORMONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.80-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
NPS Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
84Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
33JPRN-UMIN0000021552009/09/012 April 2019Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomyPostoperative hypoparathyroidismIn the first day after operation, we start administration of falecalcitriol at a dosage of 0.6ug once a day, when below the lower limit of serum calcium. If serum calcium level do not reach normal range, we escalete to 0.9ug/day.Oral calcium lactate is administered 3g/day in all enrolled patients.The dose is reduced when serum calcium and intact PTH level are maintained within normal range. If subjective symptoms such as tetany are worsen up, we start administration of calcium via DIV.kawasaki medicak schoolNot RecruitingNot applicableNot applicableMale and Female30Phase 3Japan
34NCT00824226January 200919 February 2015Magnesium Treatment in HypoparathyroidismEffect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid PatientsHypoparathyroidismDietary Supplement: magnesiumUniversity of TartuNot recruiting18 YearsN/ABoth10N/AEstonia
35NCT00732615December 200819 October 2017Use 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: NPSP558ShireNot recruiting18 Years85 YearsAll124Phase 3United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
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size
PhaseCountries
36NCT00743782August 22, 200811 November 2019Comparing 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)Not recruiting7 Years70 YearsAll24Early Phase 1United States
37NCT00730210June 200819 February 2015Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of LifeTreatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of LifeHypoparathyroidismDrug: a: PTH (1-84);Drug: b:placeboUniversity of AarhusNot recruiting25 Years80 YearsBoth62Phase 2Denmark
38EUCTR2008-000606-36-DK07/04/200819 March 2012Treatment 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 - HypoPTHypoparathyroidism
MedDRA version: 9.1 Level: LLT Classification code 10021041 Term: Hypoparathyroidism
Trade Name: Preotact
Product Name: parathyroid hormone (rdna)
Product Code: SUB21634
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Parathyroideahormon
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Aarhus University Hospital, Dept of Endocrinology and Metabolism CNot RecruitingFemale: yes
Male: yes
60Denmark
39NCT00395538October 30, 20062 September 2019Effects of PTH Replacement on Bone in HypoparathyroidismEffects of PTH Replacement on Bone in HypoparathyroidismHypoparathyroidism;DiGeorge SyndromeDrug: PTH 1-34National Institute of Dental and Craniofacial Research (NIDCR)Not recruiting18 Years70 YearsAll46Phase 3United States;Austria;Italy
40JPRN-UMIN0000004752006/07/012 April 2019Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administrationRelative hypoparathyoidism in maintenance hemodialysis patientsReplacement of calcium carbonate with sevelamer hydrochloride as phosphate binderHokusetsu ROD Study GroupNot Recruiting20years-oldNot applicableMale and Female40Not applicableJapan
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
41NCT00566488January 200520 May 2019Parathyroid 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 GmbHNot recruitingN/A24 MonthsAll25Phase 1United States
42NCT00581828January 200519 October 2017Does Treatment of Hypovitaminosis D Increase Calcium Absorption?Does Treatment of Hypovitaminosis D Increase Calcium Absorption?Osteoporosis;Osteopenia;Vitamin D Deficiency;Hypoparathyroidism;Hypercalciuria;HypercalcemiaDrug: Vitamin DUniversity of Wisconsin, MadisonNot recruitingN/AN/AFemale19Phase 4United States
43NCT00004361July 199519 February 2015Study 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 ChicagoNot recruiting18 YearsN/ABoth150N/A
44NCT00001304October 199119 October 2017Treatment 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)Not recruiting17 Years69 YearsAll27Phase 2United States

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