171. ウィルソン病 Wilson disease Clinical trials / Disease details


臨床試験数 : 79 薬物数 : 77 - (DrugBank : 17) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 30

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-003876-29-BE
(EUCTR)
31/07/201913/05/2019Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Cuprior 150 mg film-coated tablets
Product Name: TETA 4HCl
Product Code: TETA 4HCl
INN or Proposed INN: Trientine tetrahydrochloride
Other descriptive name: TETA 4HCl
Trade Name: Artamin 150 mg
Product Name: D-penicillamine 150mg
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
Trade Name: Artamin 250 mg
Product Name: D-penicillamine 250 mg
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
OrphalanNULLNot RecruitingFemale: yes
Male: yes
55Phase 3France;United States;Poland;Brazil;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
2NCT03539952
(ClinicalTrials.gov)
June 4, 20184/5/2018Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's DiseaseCHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's DiseaseWilson DiseaseDrug: TETA 4HCL;Drug: PenicillamineOrphalanNULLCompleted18 Years75 YearsAll53Phase 3United States;Belgium;Brazil;Denmark;France;Germany;Italy;Poland;United Kingdom;Sweden
3EUCTR2016-003876-29-IT
(EUCTR)
13/12/201706/02/2018Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease - Chelate Study: Trientine for the treatment of Wilson's disease Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: TETA.4HCI
Product Code: TETA.4HCI
INN or Proposed INN: Trientine tetrahydrochloride
Trade Name: PEMINE - 150 MG CAPSULE RIGIDE 50 CAPSULE
INN or Proposed INN: D-penicillamine
GMP ORPHAN SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3France;United States;Poland;Micronesia, Federated States of;Brazil;Denmark;Austria;Germany;United Kingdom;Italy
4EUCTR2016-003876-29-DE
(EUCTR)
15/09/201703/04/2017Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Cuprior 150 mg film-coated tablets
Product Name: TETA 4HCl
Product Code: TETA 4HCl
INN or Proposed INN: Trientine tetrahydrochloride
Other descriptive name: TETA 4HCl
Trade Name: Metalcaptase® 150 mg gastro-resistant tablet
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
Trade Name: Metalcaptase® 300 mg gastro-resistant tablet
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
OrphalanNULLNot RecruitingFemale: yes
Male: yes
55Phase 3France;United States;Poland;Belgium;Brazil;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
5EUCTR2016-003876-29-DK
(EUCTR)
16/05/201729/03/2017Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Cuprior 150 mg film-coated tablets
Product Name: TETA 4HCl
Product Code: TETA 4HCl
INN or Proposed INN: Trientine tetrahydrochloride
Other descriptive name: TETA 4HCl
Product Name: D-penicillamine 150mg
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
Product Name: D-penicillamine 250 mg
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
OrphalanNULLNot RecruitingFemale: yes
Male: yes
55Phase 3France;United States;Poland;Belgium;Brazil;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
6EUCTR2016-003876-29-AT
(EUCTR)
12/04/201710/04/2017Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: TETA 4HCl
Product Code: TETA 4HCl
INN or Proposed INN: Trientine tetrahydrochloride
Other descriptive name: TETA 4HCl
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
gmp-orphan SANULLNot Recruiting Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Brazil;Denmark;Austria;Germany;Italy;United Kingdom
7EUCTR2016-003876-29-GB
(EUCTR)
10/04/201704/04/2017Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease - CHELATE STUDY GMPO-131-002 Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Cuprior 150mg film-coated tablets
Product Name: Cuprior 150mg film-coated tablets
Product Code: TETA.4HCl
INN or Proposed INN: Trientine tetrahydrochloride
Other descriptive name: TETA 4HCl
INN or Proposed INN: D-penicillamine
Other descriptive name: D-penicillamine
INN or Proposed INN: D-penicillamine
Other descriptive name: D-penicillamine
gmp-orphan SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3France;United States;Poland;Brazil;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden