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 | EUCTR2017-003067-36-DK (EUCTR) | 08/08/2018 | 08/06/2018 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | Denmark;United States;Hungary;Canada | ||
| 2 | EUCTR2017-003067-36-HU (EUCTR) | 28/06/2018 | 25/04/2018 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | United States;Hungary;Canada;Denmark | ||
| 3 | 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 |
| 4 | EUCTR2017-000284-32-NL (EUCTR) | 04/06/2018 | 01/11/2017 | Symptom 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. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 5 | EUCTR2017-000284-32-NO (EUCTR) | 02/05/2018 | 14/11/2017 | Symptom 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. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2017-000284-32-PT (EUCTR) | 02/04/2018 | 16/11/2017 | Symptom 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 7 | EUCTR2017-000284-32-BE (EUCTR) | 30/03/2018 | 18/12/2017 | Symptom 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 8 | EUCTR2017-000284-32-IT (EUCTR) | 13/03/2018 | 31/01/2018 | Symptom 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3;Phase 4 | United States;Portugal;France;Spain;Belgium;Denmark;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 9 | EUCTR2017-000284-32-GB (EUCTR) | 05/02/2018 | 27/10/2017 | Symptom 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | United States;United Kingdom;Portugal;Spain;Canada;Netherlands;Sweden;Belgium;Norway;Denmark;Italy;France;Germany | ||
| 10 | EUCTR2017-000284-32-SE (EUCTR) | 18/01/2018 | 02/11/2017 | Symptom 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. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 11 | EUCTR2017-000284-32-DK (EUCTR) | 10/01/2018 | 09/11/2017 | Symptom 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. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3;Phase 4 | United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden |