235. 副甲状腺機能低下症 Hypoparathyroidism Clinical trials / Disease details


臨床試験数 : 88 薬物数 : 128 - (DrugBank : 25) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 7

  
No.TrialIDDate_
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PhaseCountries
1NCT03878953
(ClinicalTrials.gov)
March 31, 202215/3/2019A 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)ShireNULLNot yet recruiting20 Years85 YearsAll12Phase 3Japan
2NCT05186883
(ClinicalTrials.gov)
March 1, 20221/12/2021Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid CellsTreatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid CellsPostoperative HypoparathyroidismBiological: Allogenic parathyroid cells;Other: Standard treatment according to the Clinical protocolsInstitute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusBelarusian State Medical UniversityNot yet recruiting18 Years70 YearsAll20Phase 1/Phase 2NULL
3NCT05117853
(ClinicalTrials.gov)
November 1, 202121/10/2021Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After ThyroidectomyThe Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical TrialThyroid Disease;Hypoparathyroidism PostproceduralDrug: Autofluorescent detection + Injection of indocyanine green;Procedure: Gold standard of visual identification and evaluation of viability of the parathyroid glands.Onze Lieve Vrouw HospitalNULLNot yet recruiting18 YearsN/AAll300Phase 3Belgium
4NCT05130476
(ClinicalTrials.gov)
October 1, 20218/11/2021Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During ThyroidectomyIntraoperative Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Total and Completion Thyroidectomy: a Matched Cohort StudyHypoparathyroidism PostproceduralProcedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiographyOdense University HospitalNULLRecruiting18 YearsN/AAll139N/ADenmark
5JPRN-jRCT2051210058
02/08/202130/07/2021A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Japanese Adults With HypoparathyroidismA Phase 3, Multicenter, Single Arm, Open-Label Trial, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Japanese Adult Subjects with Hypoparathyroidism - PaTHway Japan Trial HypoparathyroidismTransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for SC injection.
All subjects will start with study drug 18 microgram/day and will be administered study drug once daily subcutaneously. Subjects will be individually and progressively titrated to an optimal dose in dose increments (increase or decrease) of 3 microgram/day.
Chessler D. StevenNULLRecruiting>= 18age oldNot applicableBoth12Phase 3Japan
6ChiCTR2100047758
2021-07-012021-06-26A medical records based study for observation of Teriparatidec in the treatment of congenital hypoparathyroidismThe observation of Teriparatide in the treatment of congenital hypoparathyroidism Congenital HypoparathyroidismTeriparatide group:No;Control group:No;The Seventh Medical Center, PLA General HospitalNULLPending018BothTeriparatide group:5;Control group:5;China
7NCT04785443
(ClinicalTrials.gov)
June 22, 202125/2/2021Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total ThyroidectomyContribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total ThyroidectomyThyroid DiseasesDrug: ICG;Procedure: Control groupUniversity Hospital, BrestNULLRecruiting18 YearsN/AAll242Phase 3France
8JPRN-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
9EUCTR2020-003380-26-FR
(EUCTR)
15/03/202127/10/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, 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 Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleava
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
10NCT04671719
(ClinicalTrials.gov)
March 10, 202111/12/2020Determination of Circulating Autotaxin in Patients With GNAS or PTH AbnormalitiesAutotaxin in Patients With GNAS/PTH AbnormalitiesFibrous Dysplasia;Albright Syndrome;Adult Children;Hypoparathyroidism;Hyperparathyroidism;Pseudo HypoparathyroidismBiological: blood sampleHospices Civils de LyonNULLRecruiting10 YearsN/AAll110France
11NCT04750460
(ClinicalTrials.gov)
March 20212/2/2021Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized TrialSecondary Hyperparathyroidism;Chronic Kidney Disease-Mineral and Bone Disorder;Dialysis;Hypocalcemia;HypoparathyroidismDrug: TeriparatideSaint Petersburg State University, RussiaNULLEnrolling by invitation18 YearsN/AAll20Phase 3Russian Federation
12EUCTR2020-003380-26-DE
(EUCTR)
25/02/202102/11/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, 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 Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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-DI
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
13NCT04701203
(ClinicalTrials.gov)
February 16, 20216/1/2021A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With HypoparathyroidismPaTHway TRIAL: A Phase 3, 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: PlaceboAscendis Pharma Bone Diseases A/SNULLActive, not recruiting18 YearsN/AAll82Phase 3United States;Canada;Denmark;Germany;Hungary;Italy;Norway
14EUCTR2020-005189-32-FR
(EUCTR)
09/02/202104/12/2020Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomyContribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy - HYPOCAAVI Thyroidectomy total
MedDRA version: 20.0;Level: LLT;Classification code 10043777;Term: Thyroidectomy total;System Organ Class: 100000004865;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: InfracyanineCHRU de BrestNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
242Phase 3France
15EUCTR2020-003380-26-IT
(EUCTR)
21/01/202124/05/2021PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, 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 Hypoparathyroidism - PaTHway Trial Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-
Product Name: TransCon PTH mid-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-
Product Name: TransCon PTH high-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Te
Ascendis Pharma Bone Disease A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3France;United States;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
16EUCTR2020-003380-26-HU
(EUCTR)
08/01/202102/11/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, 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 Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleava
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
17EUCTR2020-003380-26-DK
(EUCTR)
05/01/202120/10/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, 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 Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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-DI
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
18ChiCTR2100041719
2021-01-042021-01-02A clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidismA clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidism hypoparathyroidismPTH naked plasmid-1:PTH naked plasmid 500 µg,/kg,ih+Calcium agent;PTH naked plasmid-2:PTH naked plasmid 300 µg,/kg,ih+Calcium agent;PTH naked plasmid-3:PTH naked plasmid 100 µg,/kg,ih+Calcium agent;PTH-rhMSC-1:PTH-rhMSC 10^6/ kg,ih+Calcium agent;PTH-rhMSC-2:PTH-rhMSC 10^7/ kg,ih+Calcium agent;PTH-rhMSC-3:PTH-rhMSC 10^8/ kg,ih+Calcium agent;Calcium agent therapy control:Calcium +Calcitriol;pcDNA3.1 control:pcDNA3.1 +Calcium agent;uninfected MSC control:uninfected MSC+Calcium agent;Shenzhen Ruipuxun Academy for Stem Cell & Regenerative MedicineNULLRecruiting1865BothPTH naked plasmid-1:50;PTH naked plasmid-2:50;PTH naked plasmid-3:50;PTH-rhMSC-1:50;PTH-rhMSC-2:50;PTH-rhMSC-3:50;Calcium agent therapy control:50;pcDNA3.1 control:50;uninfected MSC control:50;Phase 1-2China
19EUCTR2020-003380-26-NO
(EUCTR)
16/12/202026/10/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, 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 Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Palopegteriparatide
Other descriptive name: 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-DI
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3United States;France;Hungary;Canada;Denmark;Germany;Norway;United Kingdom;Italy
20NCT05239221
(ClinicalTrials.gov)
September 7, 20207/1/2022AZP-3601 SAD and MAD Study in Healthy Subjects and Subjects With HypoparathyroidismA Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZP-3601, a Synthetic Parathyroid Hormone Analog, in Healthy Subjects and in Subjects With HypoparathyroidismChronic HypoparathyroidismDrug: AZP-3601;Drug: PlaceboAmolyt PharmaNULLRecruiting18 Years75 YearsAll130Phase 1Hungary;Netherlands
21NCT04209179
(ClinicalTrials.gov)
July 23, 202028/11/2019A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With HypoparathyroidismA Randomized, Double-Blind, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PCO371 in Patients With HypoparathyroidismHypoparathyroidismDrug: PCO371;Drug: PlaceboChugai PharmaceuticalNULLTerminated18 YearsN/AAll5Phase 1United States;Canada;Hungary
22NCT04465227
(ClinicalTrials.gov)
July 15, 20209/7/2020Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX-305 in Autosomal Dominant Hypocalcemia Type 1 (ADH1)A Phase IIb, Open-label Dose-ranging Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX Hypocalcemia Type l (ADHl).HypoparathyroidismDrug: CLTX-305National Institute of Dental and Craniofacial Research (NIDCR)NULLNot yet recruiting16 YearsN/AAll20Phase 2United States
23NCT04412694
(ClinicalTrials.gov)
July 1, 202023/5/2020The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients.The Impact of Preoperative Oral Dexamethasone Supplementation on the Biochemical Parameters and Results of Surgical Treatment in Patients With Nontoxic Multinodular Goiter Undergoing Total Thyroidectomy.Hypocalcemia;Vitamin D Deficiency;Postoperative Complications;Postoperative Nausea;Postoperative Pain;Voice Hoarseness;Hypoparathyroidism PostproceduralDrug: Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland).;Drug: Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria).;Diagnostic Test: Preoparative blood laboratory tests;Diagnostic Test: Postoperative laboratory blood tests at 6 hour;Diagnostic Test: Postoperative laboratory blood tests at 24 hour;Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour;Procedure: Total thyroidectomy;Other: Symptomatic hypocalcaemia at 6 hour;Other: Symptomatic hypocalcaemia at 24 hour;Other: Postoperative pain at 6 hour;Other: Postoperative pain at 24 hour;Other: Postoperative nausea and vomiting at 6 hour;Other: Postoperative nausea and vomiting at 24 hour;Other: Postoperative sore throat and hoarseness at 6 hour;Other: Postoperative sore throat and hoarseness at 24 hourMedical University of LodzNULLRecruiting18 Years100 YearsAll100Phase 4Poland
24EUCTR2019-003506-26-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
25EUCTR2018-004815-33-IT
(EUCTR)
18/11/201917/06/2021PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.PaTH 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 Hypoparathyroidism - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Product Name: TransCon PTH mid-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Product Name: TransCon PTH high-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Disease A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;United Kingdom;Italy
26NCT03425747
(ClinicalTrials.gov)
October 15, 201927/1/2018Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic HypoparathyroidismCALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISMChronic HypoparathyroidismDrug: Calcium Carbonate;Drug: Calcium CitrateCampus Bio-Medico UniversityNULLCompleted18 Years75 YearsAll26Phase 4Italy
27EUCTR2018-004815-33-GB
(EUCTR)
08/10/201906/02/2020PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.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 Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;United Kingdom
28EUCTR2018-004815-33-NO
(EUCTR)
27/09/201920/03/2019PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.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 Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;Norway;Italy;United Kingdom
29NCT04009291
(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
30EUCTR2018-004815-33-DK
(EUCTR)
05/07/201927/05/2019PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.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 Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), A
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;United Kingdom
31NCT04126941
(ClinicalTrials.gov)
June 1, 201911/10/2019Monocentric 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 LyonNULLRecruiting2 Years18 YearsAll9France
32ChiCTR1900022194
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
33NCT03364738
(ClinicalTrials.gov)
September 26, 201820/11/2017Safety 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)ShireNULLCompleted18 YearsN/AAll22Phase 3United States;Canada;Denmark;Hungary
34EUCTR2017-003067-36-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
35EUCTR2017-003067-36-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.NULLNot RecruitingFemale: yes
Male: yes
32Phase 3United States;Hungary;Canada;Denmark
36NCT03516773
(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
37EUCTR2017-000284-32-NL
(EUCTR)
04/06/201801/11/2017Symptom 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
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
38EUCTR2017-000284-32-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: 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
92Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
39EUCTR2017-000284-32-BE
(EUCTR)
30/03/201818/12/2017Symptom 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
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
40EUCTR2017-000284-32-IT
(EUCTR)
13/03/201831/01/2018Symptom 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)] - A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and M 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
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3;Phase 4United States;Portugal;France;Spain;Belgium;Denmark;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
41NCT03324880
(ClinicalTrials.gov)
February 15, 201810/10/2017A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)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)]HypoparathyroidismBiological: rhPTH(1-84);Biological: PlaceboShireNULLRecruiting18 Years85 YearsAll150Phase 4United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
42EUCTR2017-000284-32-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]
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 finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
43EUCTR2017-000284-32-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
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
44EUCTR2017-000284-32-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.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
45NCT03249012
(ClinicalTrials.gov)
September 1, 20179/8/2017Quality 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 LavalNULLRecruiting18 YearsN/AAll120N/ACanada
46NCT02824718
(ClinicalTrials.gov)
June 6, 20171/7/2016Recombinant 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 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, FranceCompleted18 Years80 YearsAll16Phase 2France
47NCT03150108
(ClinicalTrials.gov)
May 16, 20171/5/2017Study 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)ShireNULLCompleted18 Years65 YearsAll24Phase 1United States
48NCT02781844
(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
49NCT04146259
(ClinicalTrials.gov)
January 1, 201729/10/2019Changes in Circulating Sclerostin Levels During Acute Postsurgical HypoparathyroidismChanges in Circulating Sclerostin Levels During Acute Postsurgical HypoparathyroidismHypoparathyroidism PostproceduralDrug: calcium carbonate and alphacalcidolUniversity of AthensNULLCompleted19 YearsN/AFemale109Greece
50NCT04012476
(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
51NCT02910466
(ClinicalTrials.gov)
October 27, 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 YearsAll39Phase 4United States
52EUCTR2016-000500-29-FR
(EUCTR)
03/06/201626/04/2016A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant HypocalcemiaA randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia - ACTICAS Autosomal dominant hypocalcemia (ADH)
MedDRA version: 19.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: FORSTEO-R
Product Name: FORSTEO-R
INN or Proposed INN: Tériparatide
Other descriptive name: FORSTEO-R
Trade Name: ESIDREX-R 25 mg
Product Name: ESIDREX-R 25 mg
INN or Proposed INN: Hydrochlorothiazide
Other descriptive name: ESIDREX-R
Trade Name: UN-ALPHA-R 0.25µg
Product Name: UN-ALPHA-R 0.25µg
INN or Proposed INN: Alfacalcidol
Other descriptive name: UN-ALPHA-R
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
25Phase 2France
53NCT02986607
(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
54NCT02652884
(ClinicalTrials.gov)
January 20165/1/2016Steroids 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 AiresNULLRecruiting18 YearsN/ABoth110Phase 4Argentina
55EUCTR2015-003108-22-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
56NCT02152228
(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
57NCT04690842
(ClinicalTrials.gov)
June 201428/12/2020Improving Safety in Pediatric Thyroidectomy by PTH MeasurementsImplementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric PatientsHypoparathyroidism PostproceduralDiagnostic Test: PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)Hospital de Niños R. Gutierrez de Buenos AiresNULLCompleted2 Years19 YearsAll66NULL
58EUCTR2013-001890-26-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
59NCT01815021
(ClinicalTrials.gov)
April 20137/3/2013A 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.NULLCompleted18 Years80 YearsBoth10Phase 1/Phase 2Israel
60NCT02924532
(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
61NCT01455181
(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
62EUCTR2011-001265-40-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
63NCT01297309
(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
64NCT01268098
(ClinicalTrials.gov)
February 9, 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
65EUCTR2008-005063-34-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
66NCT01171690
(ClinicalTrials.gov)
November 201027/7/2010Teriparatide for Postsurgical HypoparathyroidismPilot Study of Teriparatide for Postsurgical HypoparathyroidismHypoparathyroidism Post-surgicalDrug: TeriparatideMayo ClinicNULLTerminated18 Years80 YearsAll5Phase 2United States
67EUCTR2008-005063-34-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
68NCT00856401
(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
69NCT01199614
(ClinicalTrials.gov)
December 20099/9/2010HEXT (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;ShireActive, not recruiting18 Years85 YearsAll75Phase 3United States
70EUCTR2008-005063-34-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
71JPRN-UMIN000002155
2009/09/0106/07/2009Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy Postoperative 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 schoolNULLComplete: follow-up completeNot applicableNot applicableMale and Female30Phase 3Japan
72EUCTR2008-005063-34-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
73EUCTR2008-005063-34-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:
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 Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom
74EUCTR2008-005063-34-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
75NCT00824226
(ClinicalTrials.gov)
January 200915/1/2009Magnesium Treatment in HypoparathyroidismEffect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid PatientsHypoparathyroidismDietary Supplement: magnesiumUniversity of TartuNULLCompleted18 YearsN/ABoth10N/AEstonia
76NCT00732615
(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
77EUCTR2008-005063-34-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
78NCT00743782
(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
79NCT00730210
(ClinicalTrials.gov)
June 20084/8/2008Treatment 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 AarhusNULLCompleted25 Years80 YearsBoth62Phase 2Denmark
80EUCTR2008-000606-36-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
60Phase 4Denmark
81NCT00395538
(ClinicalTrials.gov)
October 30, 20062/11/2006Effects 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)NULLTerminated18 Years70 YearsAll46Phase 3United States;Austria;Italy
82JPRN-UMIN000000475
2006/07/0101/09/2006Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration Relative hypoparathyoidism in maintenance hemodialysis patientsReplacement of calcium carbonate with sevelamer hydrochloride as phosphate binderHokusetsu ROD Study GroupNULLComplete: follow-up complete20years-oldNot applicableMale and Female40Not applicableJapan
83NCT00566488
(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
84NCT00581828
(ClinicalTrials.gov)
January 200519/12/2007Does 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, MadisonNULLCompletedN/AN/AFemale19Phase 4United States
85NCT00473265
(ClinicalTrials.gov)
May 200414/5/2007Bone Properties in Hypoparathyroidism: Effects of PTHBone Properties in Hypoparathyroidism: Effects of PTHHypoparathyroidismDrug: PTHJohn P. BilezikianNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll68Phase 2/Phase 3United States
86NCT00004361
(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
87NCT00001304
(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
88EUCTR2018-004815-33-DE
(EUCTR)
28/03/2019PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.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 Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: 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)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany