TransCon PTH ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 235 | 副甲状腺機能低下症 | 14 |
235. 副甲状腺機能低下症
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. | 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 | JPRN-jRCT2051210058 | 02/08/2021 | 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. | Chessler D. Steven | NULL | Recruiting | >= 18age old | Not applicable | Both | 12 | Phase 3 | Japan |
| 2 | 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 | ||
| 3 | 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 | United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy | ||
| 4 | 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 |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | 40 | Phase 2 | United States;Canada;Denmark;Germany;Italy;Norway;United Kingdom |
| 13 | 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 | ||
| 14 | 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 |