Natpar ( 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11

235. 副甲状腺機能低下症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003067-36-DK
(EUCTR)
08/08/201808/06/2018A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 3Denmark;United States;Hungary;Canada
2EUCTR2017-003067-36-HU
(EUCTR)
28/06/201825/04/2018A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism.An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Trade Name: Natpara
Product Name: Human recombinant parathyroid Hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: PARATHYROID HORMONE
Other descriptive name: Parathyroid Hormone
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 3United States;Hungary;Canada;Denmark
3NCT03516773
(ClinicalTrials.gov)
June 17, 201823/4/2018Oral PTH(1-34) PK and PD Study in Patients With HypoparathyroidismAn Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Parathyroid Hormone [PTH (1-34)] and NATPARA® in Patients With HypoparathyroidismHypoparathyroidismDrug: EB612 (EBP05);Drug: NATPARA/NATPAREntera Bio Ltd.NULLCompleted18 Years80 YearsAll20Phase 2Israel
4EUCTR2017-000284-32-NL
(EUCTR)
04/06/201801/11/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
5EUCTR2017-000284-32-NO
(EUCTR)
02/05/201814/11/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
6EUCTR2017-000284-32-PT
(EUCTR)
02/04/201816/11/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
7EUCTR2017-000284-32-BE
(EUCTR)
30/03/201818/12/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
8EUCTR2017-000284-32-IT
(EUCTR)
13/03/201831/01/2018Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] - A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and M Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Trade Name: Natpara
INN or Proposed INN: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Other descriptive name: ORMONE PARATIROIDEO DA DNA RICOMBINANTE
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3;Phase 4United States;Portugal;France;Spain;Belgium;Denmark;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2017-000284-32-GB
(EUCTR)
05/02/201827/10/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4United States;United Kingdom;Portugal;Spain;Canada;Netherlands;Sweden;Belgium;Norway;Denmark;Italy;France;Germany
10EUCTR2017-000284-32-SE
(EUCTR)
18/01/201802/11/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
11EUCTR2017-000284-32-DK
(EUCTR)
10/01/201809/11/2017Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)]A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Hypoparathyroidism
MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Other descriptive name: Parathyroid Hormone
Trade Name: Natpar
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden