Rhpth(1-84)    (DrugBank: rhPTH)

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23

235. 副甲状腺機能低下症 [臨床試験数:67,薬物数:112(DrugBank:24),標的遺伝子数:4,標的パスウェイ数:5
Searched query = "Hypoparathyroidism", "Accessory thyroid hypergasia disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
23 / 67 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03878953
(ClinicalTrials.gov)
March 31, 202115/3/2019A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic HypoparathyroidismA Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic HypoparathyroidismChronic HypoparathyroidismDrug: rhPTH(1-84)ShireNULLNot yet recruiting20 Years85 YearsAll12Phase 3Japan
2NCT03364738
(ClinicalTrials.gov)
September 26, 201820/11/2017Safety and Efficacy Study of rhPTH(1-84) in Subjects With HypoparathyroidismAn Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With HypoparathyroidismHypoparathyroidismBiological: rhPTH(1-84)ShireNULLCompleted18 YearsN/AAll22Phase 3United States;Canada;Denmark;Hungary
3EUCTR2017-003067-36-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
4EUCTR2017-003067-36-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 3United States;Hungary;Canada;Denmark
5EUCTR2017-000284-32-NL
(EUCTR)
04/06/201801/11/2017 Symptom Improvement Evaluation 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 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3;Phase 4Portugal;France;United States;Belgium;Spain;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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: Natpara
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: Natpara
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: Natpara
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: Natpara
Product Name: human recombinant parathyroid hormone
Product Code: rhPTH(1-84)
INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84)
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4France;United States;Portugal;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
7EUCTR2017-000284-32-BE
(EUCTR)
30/03/201818/12/2017 Symptom Improvement Evaluation 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 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3;Phase 4Portugal;France;United States;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
8NCT03324880
(ClinicalTrials.gov)
February 15, 201810/10/2017Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With HypoparathyroidismA 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)]HypoparathyroidismBiological: rhPTH(1-84);Biological: PlaceboShireNULLRecruiting18 Years85 YearsAll150Phase 4United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
9EUCTR2017-000284-32-GB
(EUCTR)
05/02/201827/10/2017 Symptom Improvement Evaluation 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 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3;Phase 4United States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3;Phase 4Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
12NCT03150108
(ClinicalTrials.gov)
May 16, 20171/5/2017Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult SubjectsA Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese SubjectsHypoparathyroidismDrug: rhPTH(1-84)ShireNULLCompleted18 Years65 YearsAll24Phase 1United States
13NCT02781844
(ClinicalTrials.gov)
April 3, 201719/4/2016Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With HypoparathyroidismAn Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With HypoparathyroidismHypoparathyroidismDrug: 25mcg rhPTH(1-84);Drug: 50mcg rhPTH(1-84);Drug: 100mcg rhPTH(1-84)ShireNULLCompleted18 YearsN/AAll34Phase 1United States;Canada;Denmark;Hungary
14NCT02910466
(ClinicalTrials.gov)
December 9, 201620/9/2016A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in HypoparathyroidismA Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in HypoparathyroidismChronic Hypoparathyroidism;HypoparathyroidismDrug: rhPTH(1-84)ShireNULLCompleted18 Years85 YearsAll36Phase 4United States
15EUCTR2011-001265-40-HU
(EUCTR)
29/07/201123/05/2011A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with HypoparathyroidismA 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults with Hypoparathyroidism - A Clinical Extension Study - Not applicable Hypoparathyroidism
MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
30Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01268098
(ClinicalTrials.gov)
January 201128/12/2010Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With HypoparathyroidismHypoparathyroidismDrug: NPSP558ShireNULLCompleted18 Years85 YearsAll42Phase 3United States
17EUCTR2008-005063-34-LT
(EUCTR)
29/11/201016/08/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.0;Level: PT;Classification code 10021041;Term:
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Trade Name: PREOTACT
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
18EUCTR2008-005063-34-HU
(EUCTR)
27/09/201004/10/2010A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
110Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
19EUCTR2008-005063-34-FR
(EUCTR)
14/09/200914/11/2008A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 9.1;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
20EUCTR2008-005063-34-DK
(EUCTR)
27/08/200917/11/2008A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.0;Level: PT;Classification code 10021041;Term:
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
110Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2008-005063-34-GB
(EUCTR)
04/08/200922/05/2009A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 13.0;Level: PT;Classification code 10021041;Term:
NPS Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
110Phase 3France;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom
22EUCTR2008-005063-34-IT
(EUCTR)
27/04/200918/06/2009A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040 Hypoparatthyroidism
MedDRA version: 12.0;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism
Product Code: NPSP 558
Product Code: NPSP 558
Product Code: NPSP 558
NPS PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania
23EUCTR2008-005063-34-BE
(EUCTR)
18/11/200818/11/2008A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicableA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable Hypoparathyroidism
MedDRA version: 12.0;Level: PT;Classification code 10021041;Term:
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
INN or Proposed INN: Parathyroid Hormone
Other descriptive name: PARATHYROID HORMONE
NPS Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Lithuania;Denmark;Italy;United Kingdom;France;Hungary;Belgium