235. 副甲状腺機能低下症 Hypoparathyroidism Clinical trials / Disease details
臨床試験数 : 88 / 薬物数 : 107 - (DrugBank : 24) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 7
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05735015 (ClinicalTrials.gov) | March 22, 2023 | 17/2/2023 | Study of the PTH-independent Effects of Encaleret on Mineral Homeostasis in Subjects With Postsurgical Hypoparathyroidism (PSH) | Phase 2 Study of the PTH-Independent Effects of Encaleret on Mineral Homeostasis in Subjects With Post-Surgical Hypoparathyroidism (PSH) | Post-Surgical Hypoparathyroidism | Drug: encaleret | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Not yet recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 2 | NCT05654701 (ClinicalTrials.gov) | March 2023 | 8/12/2022 | Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism | Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism | Hypoparathyroidism | Drug: Palopegteriparatide (TransCon PTH) | Ascendis Pharma Bone Diseases A/S | NULL | Available | 18 Years | N/A | All | NULL | ||
| 3 | JPRN-jRCT2051210058 | 02/11/2021 | 30/07/2021 | A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Japanese Adults With Hypoparathyroidism | A 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 | Hypoparathyroidism | TransCon 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. | Sibley Christopher | NULL | Recruiting | >= 18age old | Not applicable | Both | 12 | Phase 3 | Japan |
| 4 | NCT05387070 (ClinicalTrials.gov) | July 28, 2021 | 18/5/2022 | PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism | PaTHway CHINA 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 Hypoparathyroidism | Hypoparathyroidism;Parathyroid Hormone Deficiency;Endocrine System Diseases;Parathyroid Diseases | Drug: TransCon PTH;Drug: placebo | Visen Pharmaceuticals (Shanghai) Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 76 | Phase 3 | China |
| 5 | EUCTR2020-003380-26-FR (EUCTR) | 15/03/2021 | 27/10/2020 | PaTHway 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
| 6 | NCT04671719 (ClinicalTrials.gov) | March 10, 2021 | 11/12/2020 | Determination of Circulating Autotaxin in Patients With GNAS or PTH Abnormalities | Autotaxin in Patients With GNAS/PTH Abnormalities | Fibrous Dysplasia;Albright Syndrome;Adult Children;Hypoparathyroidism;Hyperparathyroidism;Pseudo Hypoparathyroidism | Biological: blood sample | Hospices Civils de Lyon | NULL | Recruiting | 10 Years | N/A | All | 110 | France | |
| 7 | EUCTR2020-003380-26-DE (EUCTR) | 25/02/2021 | 02/11/2020 | PaTHway 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | France;United States;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
| 8 | NCT04701203 (ClinicalTrials.gov) | February 16, 2021 | 6/1/2021 | A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism | PaTHway 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 Hypoparathyroidism | Hypoparathyroidism;Endocrine System Diseases;Parathyroid Diseases | Combination Product: TransCon PTH;Combination Product: Placebo | Ascendis Pharma Bone Diseases A/S | NULL | Active, not recruiting | 18 Years | N/A | All | 82 | Phase 3 | United States;Canada;Denmark;Germany;Hungary;Italy;Norway |
| 9 | EUCTR2020-003380-26-IT (EUCTR) | 21/01/2021 | 24/05/2021 | PaTHway 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | France;United States;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2020-003380-26-HU (EUCTR) | 08/01/2021 | 02/11/2020 | PaTHway 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
| 11 | EUCTR2020-003380-26-DK (EUCTR) | 05/01/2021 | 20/10/2020 | PaTHway 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
| 12 | ChiCTR2100041719 | 2021-01-04 | 2021-01-02 | A clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidism | A clinical study of efficacy and safety for PTH recombinant plasmid and PTH rhMSC therapy in the patients with hypoparathyroidism | hypoparathyroidism | PTH 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 Medicine | NULL | Recruiting | 18 | 65 | Both | PTH 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 1-2 | China |
| 13 | EUCTR2020-003380-26-NO (EUCTR) | 16/12/2020 | 26/10/2020 | PaTHway 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | United States;France;Hungary;Canada;Denmark;Germany;Norway;United Kingdom;Italy | ||
| 14 | EUCTR2018-004815-33-IT (EUCTR) | 18/11/2019 | 17/06/2021 | PaTH 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;United Kingdom;Italy | ||
| 15 | EUCTR2018-004815-33-GB (EUCTR) | 08/10/2019 | 06/02/2020 | PaTH 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;United Kingdom | ||
| 16 | EUCTR2018-004815-33-NO (EUCTR) | 27/09/2019 | 20/03/2019 | PaTH 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;Norway;Italy;United Kingdom | ||
| 17 | NCT04009291 (ClinicalTrials.gov) | August 27, 2019 | 20/6/2019 | A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH 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 | Hypoparathyroidism;Endocrine System Diseases;Parathyroid Diseases | Combination Product: TransCon PTH;Combination Product: Placebo for TransCon PTH | Ascendis Pharma A/S | NULL | Active, not recruiting | 18 Years | N/A | All | 59 | Phase 2 | United States;Canada;Denmark;Germany;Italy;Norway;United Kingdom |
| 18 | EUCTR2018-004815-33-DK (EUCTR) | 05/07/2019 | 27/05/2019 | PaTH 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany;United Kingdom | ||
| 19 | NCT03516773 (ClinicalTrials.gov) | June 17, 2018 | 23/4/2018 | Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism | An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Parathyroid Hormone [PTH (1-34)] and NATPARA® in Patients With Hypoparathyroidism | Hypoparathyroidism | Drug: EB612 (EBP05);Drug: NATPARA/NATPAR | Entera Bio Ltd. | NULL | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | Israel |
| 20 | NCT02152228 (ClinicalTrials.gov) | July 2014 | 22/4/2014 | A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism | A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism | Hypoparathyroidism | Drug: EnteraBio's Oral Parathyroid Hormone (1-34) | Entera Bio Ltd. | NULL | Completed | 18 Years | 80 Years | Both | 20 | Phase 2 | Israel |
| 21 | EUCTR2013-001890-26-IT (EUCTR) | 06/05/2014 | 27/03/2014 | Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism | Recombinant 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 Firenze | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Italy | ||
| 22 | NCT00856401 (ClinicalTrials.gov) | September 2010 | 4/3/2009 | ADD-ON Study to Existing Hypoparathyroidism Studies | Phase II Trial of Parathyroid Hormone for the Treatment of Hypoparathyroidism | Hypoparathyroidism | Drug: PTH1-84 in parent study | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Active, not recruiting | 18 Years | 85 Years | All | 62 | Phase 3 | United States |
| 23 | NCT01199614 (ClinicalTrials.gov) | December 2009 | 9/9/2010 | HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism | HEXT: The Hypoparathyroidism Studies, EXTended: The Effect of PTH on the Skeleton in Hypoparathyroidism | Hypoparathyroidism | Drug: open-label PTH(1-84) | John P. Bilezikian | NPS Pharma;Shire | Active, not recruiting | 18 Years | 85 Years | All | 75 | Phase 3 | United States |
| 24 | JPRN-UMIN000002155 | 2009/09/01 | 06/07/2009 | Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy | Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy - Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy | Postoperative hypoparathyroidism | In 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 school | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 30 | Phase 3 | Japan |
| 25 | NCT00743782 (ClinicalTrials.gov) | August 22, 2008 | 28/8/2008 | Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism | Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism | Hypoparathyroidism;Hypocalcemia | Drug: Synthetic Human Parathyroid Hormone 1-34 | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | 7 Years | 70 Years | All | 24 | Early Phase 1 | United States |
| 26 | NCT00730210 (ClinicalTrials.gov) | June 2008 | 4/8/2008 | Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life | Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life | Hypoparathyroidism | Drug: a: PTH (1-84);Drug: b:placebo | University of Aarhus | NULL | Completed | 25 Years | 80 Years | Both | 62 | Phase 2 | Denmark |
| 27 | EUCTR2008-000606-36-DK (EUCTR) | 07/04/2008 | 25/03/2008 | Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT | Treatment 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 C | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Denmark | ||
| 28 | NCT00395538 (ClinicalTrials.gov) | October 30, 2006 | 2/11/2006 | Effects of PTH Replacement on Bone in Hypoparathyroidism | Effects of PTH Replacement on Bone in Hypoparathyroidism | Hypoparathyroidism;DiGeorge Syndrome | Drug: PTH 1-34 | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Terminated | 18 Years | 70 Years | All | 46 | Phase 3 | United States;Austria;Italy |
| 29 | NCT00473265 (ClinicalTrials.gov) | May 2004 | 14/5/2007 | Bone Properties in Hypoparathyroidism: Effects of PTH | Bone Properties in Hypoparathyroidism: Effects of PTH | Hypoparathyroidism | Drug: PTH | John P. Bilezikian | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | N/A | All | 68 | Phase 2/Phase 3 | United States |
| 30 | EUCTR2018-004815-33-DE (EUCTR) | 28/03/2019 | PaTH 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Denmark;Germany |