RhPTH ( DrugBank: rhPTH )


3 diseases
IDDisease name (Link within this page)Number of trials
70Spinal stenosis1
235Hypoparathyroidism30
326Osteopetrosis1

70. Spinal stenosis


Clinical trials : 96 Drugs : 203 - (DrugBank : 60) / Drug target genes : 66 - Drug target pathways : 89
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-006152-36-DK
(EUCTR)
10/05/201210/05/2012Does postoperative treatment with parathyroidea hormone Forteo®improve the disability inelderly patients undergoing spinal stabilization fusion surgery comparedwith patients treated with placebo. If that is the case, is there a correlationbetween improvement of disability and solid osseous healing?Postoperative treatment with parathyroidea hormone Forteo® inpatients undergoing posterolateral spinal fusion surgery. A prospektiveand a randomized double-blinded, placebo-controlled study - PTH-U-DESE-STUDY Spinal stenosis
MedDRA version: 14.1;Level: LLT;Classification code 10041597;Term: Spinal stenosis of lumbar region;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Forteo
Product Name: Forsteo
Product Code: 0002-8971
INN or Proposed INN: teriparatide [rDNA origin] contains recombinant human parathyroid hormone (1-34)
Other descriptive name: rhPTH (1-34)
Middelfart RygsektorNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Denmark

235. Hypoparathyroidism


Clinical trials : 88 Drugs : 128 - (DrugBank : 25) / Drug target genes : 5 - Drug target pathways : 7
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, 202215/3/2019A 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
2JPRN-JapicCTI-194828
31/3/202125/06/2019A 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 Hypoparathyroidism Chronic HypoparathyroidismIntervention name : rhPTH (1-84)
INN of the intervention : Parathyroid hormone
Dosage And administration of the intervention : rhPTH (1-84) will be administered at 25, 50, 75 and 100 micrograms once daily in one of the thighs (alternate thigh every day) as a subcutaneous injection.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLpending2085BOTH12Phase 3Japan
3NCT03364738
(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
4EUCTR2017-003067-36-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
5EUCTR2017-003067-36-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
6EUCTR2017-000284-32-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
7EUCTR2017-000284-32-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
8EUCTR2017-000284-32-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
9EUCTR2017-000284-32-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
10NCT03324880
(ClinicalTrials.gov)
February 15, 201810/10/2017A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)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)]HypoparathyroidismBiological: rhPTH(1-84);Biological: PlaceboShireNULLRecruiting18 Years85 YearsAll150Phase 4United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
11EUCTR2017-000284-32-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]
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 finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
12EUCTR2017-000284-32-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
92Phase 3;Phase 4United States;Portugal;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
13EUCTR2017-000284-32-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
14NCT02824718
(ClinicalTrials.gov)
June 6, 20171/7/2016Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary HypoparathyroidismA Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary HypoparathyroidismAutosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under TreatmentDrug: Teriparatide;Drug: Thiazide;Drug: Potassium sparing diuretic;Drug: AlfacalcidolAssistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted18 Years80 YearsAll16Phase 2France
15NCT03150108
(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
16NCT02781844
(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
17NCT02910466
(ClinicalTrials.gov)
October 27, 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 YearsAll39Phase 4United States
18EUCTR2016-000500-29-FR
(EUCTR)
03/06/201626/04/2016A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant HypocalcemiaA randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia - ACTICAS Autosomal dominant hypocalcemia (ADH)
MedDRA version: 19.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: FORSTEO-R
Product Name: FORSTEO-R
INN or Proposed INN: Tériparatide
Other descriptive name: FORSTEO-R
Trade Name: ESIDREX-R 25 mg
Product Name: ESIDREX-R 25 mg
INN or Proposed INN: Hydrochlorothiazide
Other descriptive name: ESIDREX-R
Trade Name: UN-ALPHA-R 0.25µg
Product Name: UN-ALPHA-R 0.25µg
INN or Proposed INN: Alfacalcidol
Other descriptive name: UN-ALPHA-R
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
25Phase 2France
19NCT01455181
(ClinicalTrials.gov)
August 19, 201115/9/2011A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in HungaryA 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 StudyHypoparathyroidismDrug: NPSP558ShireNULLCompleted18 Years85 YearsAll24Phase 3Hungary
20EUCTR2011-001265-40-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
21NCT01297309
(ClinicalTrials.gov)
April 6, 201111/2/2011A 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 (RACE)A Long-term 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 (RACE)HypoparathyroidismDrug: NPSP558ShireNULLCompleted18 Years85 YearsAll51Phase 3United States
22NCT01268098
(ClinicalTrials.gov)
February 9, 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
23EUCTR2008-005063-34-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
24EUCTR2008-005063-34-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
25EUCTR2008-005063-34-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
26EUCTR2008-005063-34-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
27EUCTR2008-005063-34-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:
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 Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom
28EUCTR2008-005063-34-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
29NCT00732615
(ClinicalTrials.gov)
December 20088/8/2008Use of NPSP558 in the Treatment of HypoparathyroidismA 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 HypoparathyroidismHypoparathyroidismDrug: Placebo;Drug: NPSP558ShireNULLCompleted18 Years85 YearsAll124Phase 3United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom
30EUCTR2008-005063-34-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

326. Osteopetrosis


Clinical trials : 20 Drugs : 51 - (DrugBank : 14) / Drug target genes : 17 - Drug target pathways : 81
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00145886
(ClinicalTrials.gov)
February 20031/9/2005rhPTH Therapy for Low Turnover Bone FragilityEffect of 12 Months Treatment With rhPTH on Calcium Balance, Bone Turnover, Bone Mineral Density, and Bone Micro-architecture in Patients With Fractures Associated With Low Bone Turnover and Sclerosing Bone DisordersOsteopetrosisDrug: rhPTHUniversity of ChicagoNULLTerminated20 YearsN/ABoth2Phase 1United States