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
| 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 | EUCTR2016-003876-29-BE (EUCTR) | 31/07/2019 | 13/05/2019 | Chelate Study: Trientine for the treatment of Wilson's disease | CHELATE 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 | Orphalan | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;United States;Poland;Brazil;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 2 | EUCTR2016-003876-29-IT (EUCTR) | 13/12/2017 | 06/02/2018 | Chelate Study: Trientine for the treatment of Wilson's disease | CHELATE 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | France;United States;Poland;Micronesia, Federated States of;Brazil;Denmark;Austria;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2016-003876-29-DK (EUCTR) | 16/05/2017 | 29/03/2017 | Chelate Study: Trientine for the treatment of Wilson's disease | CHELATE 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 | Orphalan | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;United States;Poland;Belgium;Brazil;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2016-003876-29-GB (EUCTR) | 10/04/2017 | 04/04/2017 | Chelate Study: Trientine for the treatment of Wilson's disease | CHELATE 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 SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | France;United States;Poland;Brazil;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 5 | NCT02426905 (ClinicalTrials.gov) | January 2016 | 18/9/2014 | Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine | Multicentre, Retrospective and Prospective Study to Assess Long-Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine | Wilson Disease | Drug: trientine dihydrochloride | Univar BV | NULL | Active, not recruiting | 1 Year | 90 Years | All | 90 | Phase 4 | Germany;Greece;Italy;United Kingdom |
| 6 | EUCTR2013-003564-31-DE (EUCTR) | 27/02/2014 | 22/10/2013 | A study to review Wilson disease patients who have previously been prescribed d- Penicillamine but were changed to trientine as treatment for their disease, and to follow them for a further 12 months. | Multicentre, Retrospective and Prospective Study to Assess Long Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With d-Penicillamine | Wilson disease, also known as hepatolenticular degeneration, a rare automsomal, recessively inherited disorder which results in chronic copper intoxication. MedDRA version: 19.1;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Trientine dihydrochloride 300mg capsules INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE | Univar B.V. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | Germany;Italy |