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

  
19 trials found
No.TrialIDDate_
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PhaseCountries
1ChiCTR2100047758
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
2EUCTR2020-003380-26-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
3NCT04750460
(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
4EUCTR2020-003380-26-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
5EUCTR2020-003380-26-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
6EUCTR2020-003380-26-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
7EUCTR2020-003380-26-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
8EUCTR2020-003380-26-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
9EUCTR2018-004815-33-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
10EUCTR2018-004815-33-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
11EUCTR2018-004815-33-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
12EUCTR2018-004815-33-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
13NCT04126941
(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
14NCT02824718
(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
15EUCTR2013-001890-26-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
16NCT01171690
(ClinicalTrials.gov)
November 201027/7/2010Teriparatide for Postsurgical HypoparathyroidismPilot Study of Teriparatide for Postsurgical HypoparathyroidismHypoparathyroidism Post-surgicalDrug: TeriparatideMayo ClinicNULLTerminated18 Years80 YearsAll5Phase 2United States
17NCT00743782
(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
18NCT00395538
(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
19EUCTR2018-004815-33-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