171. ウィルソン病 ［臨床試験数：25，薬物数：29（DrugBank：15），標的遺伝子数：0，標的パスウェイ数：0］
Searched query = "Wilson disease"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR1900023410 | 2019-06-01 | 27 May 2019 | The application of quantitative susceptibility mapping and blood and urine cell culture in Wilson's disease | The application of quantitative susceptibility mapping and blood and urine cell culture in Wilson's disease | Wilson’s disease | Gold Standard:The main clinical diagnostic criteria: 1) liver disease history, liver disease symptoms or extravertebral system symptoms; 2) serum ceruloplasmin was significantly decreased and/or liver copper increased; 3) corneal Kayser-Fleischer ring; 4) positive family history.;Index test:Quantitative susceptibility mapping; | Shanghai Tongren Hospital | Recruiting | Both | Target condition:40;Difficult condition:20 | Phase 0 | China | |||
| 2 | NCT03957720 | March 15, 2019 | 3 June 2019 | The Individual Therapy for Patients With Wilson's Disease | The Individual Therapy for Patients With Wilson's Disease | Wilson's Disease | Drug: DMPS;Drug: Penicillamine;Drug: DMSA;Drug: Zinc gluconate | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | N/A | N/A | All | 400 | Early Phase 1 | China | |
| 3 | NCT03659331 | September 2018 | 17 September 2018 | A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease | A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease | Wilson Disease | Dietary Supplement: Zinc | Prof. Elon Pras | Not recruiting | 18 Years | N/A | All | 50 | N/A | ||
| 4 | NCT03539952 | June 4, 2018 | 4 November 2019 | Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease | CHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease | Wilson Disease | Drug: TETA 4HCL;Drug: Penicillamine | GMP-Orphan SAS | Recruiting | 18 Years | 75 Years | All | 55 | Phase 3 | United States;Belgium;Brazil;Denmark;France;Germany;Italy;Poland;Sweden;United Kingdom | |
| 5 | EUCTR2017-004135-36-ES | 27/04/2018 | 18 June 2018 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of WTX101 in adult patients who suffer from Wilson Disease. | A Phase 3, Randomised, Rater-Blinded, Multi-Centre Study to Evaluate the Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects Aged 18 and Older with an Extension Phase of up to 60 Months | Wilson Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: WTX101 Product Code: WTX101 Pharmaceutical Form: Tablet INN or Proposed INN: Not applied CAS Number: 649749-10-0 Current Sponsor code: WTX101 Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical Form: Tablet INN or Proposed INN: PENICILLAMINE CAS Number: 52-67-5 Pharmaceutical Form: Capsule INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE CAS Number: 38260-01-4 Concentration unit: g gram(s) Concentration type: range Concentration number: 1.2-2.4-(4-8 capsules) Pharmaceutical Form: Capsule INN or Proposed INN: ZINC ACETATE DIHYDRATE CAS Number: 5970-45-6 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 150-3 times daily | Wilson Therapeutics AB | Authorised | Female: yes Male: yes | 102 | Phase 3 | France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2017-004135-36-DE | 16/03/2018 | 23 July 2018 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of WTX101 in adult patients who suffer from Wilson Disease. | A Phase 3, Randomised, Rater-Blinded, Multi-Centre Study to Evaluate the Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects Aged 18 and Older with an Extension Phase of up to 60 Months | Wilson Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: WTX101 Product Code: WTX101 Pharmaceutical Form: Tablet INN or Proposed INN: Not applied CAS Number: 649749-10-0 Current Sponsor code: WTX101 Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical Form: Tablet INN or Proposed INN: PENICILLAMINE CAS Number: 52-67-5 Pharmaceutical Form: Capsule INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE CAS Number: 38260-01-4 Pharmaceutical Form: Capsule INN or Proposed INN: ZINC ACETATE DIHYDRATE CAS Number: 5970-45-6 | Wilson Therapeutics AB | Authorised | Female: yes Male: yes | 102 | Phase 3 | France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom | |||
| 7 | EUCTR2017-004135-36-AT | 27/02/2018 | 5 March 2018 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of WTX101 in adult patients who suffer from Wilson Disease. | A Phase 3, Randomised, Rater-Blinded, Multi-Centre Study to Evaluate the Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects Aged 18 and Older with an Extension Phase of up to 60 Months | Wilson Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: WTX101 Product Code: WTX101 Pharmaceutical Form: Tablet INN or Proposed INN: Not applied CAS Number: 649749-10-0 Current Sponsor code: WTX101 Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical Form: Tablet INN or Proposed INN: PENICILLAMINE CAS Number: 52-67-5 Pharmaceutical Form: Capsule INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE CAS Number: 38260-01-4 Pharmaceutical Form: Capsule INN or Proposed INN: ZINC ACETATE DIHYDRATE CAS Number: 5970-45-6 | Wilson Therapeutics AB | Authorised | Female: yes Male: yes | 102 | Phase 3 | France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom | |||
| 8 | NCT03403205 | February 15, 2018 | 11 November 2019 | Efficacy and Safety of ALXN1840 (Formerly Named WTX101) Administered for 48 Weeks Versus Standard of Care in Patients With Wilson Disease With an Extension Period of up to 60 Months | A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older With an Extension Period of Up To 60 Months | Wilson Disease | Drug: ALXN1840;Drug: SoC Therapy | Alexion Pharmaceuticals | Recruiting | 12 Years | N/A | All | 180 | Phase 3 | United States;Australia;Austria;Czechia;France;Germany;Hungary;Israel;Japan;Poland;Russian Federation;Serbia;Spain;United Kingdom;Italy | |
| 9 | EUCTR2017-004135-36-HU | 12/02/2018 | 26 February 2018 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of WTX101 in adult patients who suffer from Wilson Disease. | A Phase 3, Randomised, Rater-Blinded, Multi-Centre Study to Evaluate the Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects Aged 18 and Older with an Extension Phase of up to 60 Months | Wilson Disease MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: WTX101 Product Code: WTX101 Pharmaceutical Form: Tablet INN or Proposed INN: Not applied CAS Number: 649749-10-0 Current Sponsor code: WTX101 Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical Form: Tablet INN or Proposed INN: PENICILLAMINE CAS Number: 52-67-5 Pharmaceutical Form: Capsule INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE CAS Number: 38260-01-4 Concentration unit: g gram(s) Concentration type: range Concentration number: 1.2-2.4-(4-8 capsules) Pharmaceutical Form: Capsule INN or Proposed INN: ZINC ACETATE DIHYDRATE CAS Number: 5970-45-6 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 150-3 times daily | Wilson Therapeutics AB | Authorised | Female: yes Male: yes | 102 | Phase 3 | France;United States;Czech Republic;Hungary;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom | |||
| 10 | NCT03299829 | January 10, 2018 | 25 February 2019 | A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients | A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients | Trientine Treatment for Wilson's Disease | Drug: Trientine | Excelsior | Recruiting | 3 Years | 75 Years | All | 50 | Phase 2 | Taiwan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2016-003876-29-DK | 16/05/2017 | 28 February 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Trientine tetrahydrochloride CAS Number: 4961-40-4 Current Sponsor code: TETA 4HCl Other descriptive name: TETA 4HCl Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical Form: Film-coated tablet INN or Proposed INN: D-penicillamine CAS Number: 52-67-5 Other descriptive name: D-penicillamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical Form: Film-coated tablet INN or Proposed INN: D-penicillamine CAS Number: 52-67-5 Other descriptive name: D-penicillamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: penicillamine CAS Number: 52-67-5 Other descriptive name: penicillamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: penicillamine CAS Number: 52-67-5 Other descriptive name: penicillamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | gmp-orphan SA | Authorised | Female: yes Male: yes | 55 | Phase 3 | Sweden;Italy;United Kingdom;Germany;Denmark;Austria;Belgium;Brazil;Poland;United States;France | |||
| 12 | EUCTR2016-003876-29-AT | 12/04/2017 | 28 February 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] | Product Name: TETA 4HCl Product Code: TETA 4HCl Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Trientine tetrahydrochloride CAS Number: 4961-40-4 Current Sponsor code: TETA 4HCl Other descriptive name: TETA 4HCl Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical Form: Capsule INN or Proposed INN: penicillamine CAS Number: 52-67-5 Other descriptive name: penicillamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical Form: Capsule INN or Proposed INN: penicillamine CAS Number: 52-67-5 Other descriptive name: penicillamine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | gmp-orphan SA | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;Poland;Brazil;Denmark;Austria;Germany;Italy;United Kingdom | |||
| 13 | ChiCTR-DDD-17010552 | 2017-01-25 | 18 April 2017 | Genetic diagnosis of Wilson's disease | Genetic diagnosis of Wilson's disease | Wilson Disease | Gold Standard:Clinical symptoms; Family history of genetic; Plasma ceruloplasmin levels;Urine copper levels of 24 hours; The nervous system of assessment and head imaging examination;Index test:Determination of gene sequence of the gene of ATP7B; | Anhui Provincial Hospital | Recruiting | Both | Target condition:20;Difficult condition:0 | Diagnostic New Technique Clincal Study | China | |||
| 14 | EUCTR2013-003564-31-IT | 14/07/2016 | 30 April 2018 | 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 Study to Assess Long-Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With - N/A | Wilson disease, also known as hepatolenticular degeneration, a rare automsomal, recessively inherited disorder which results in chronic copper intoxication. MedDRA version: 20.0 Level: PT Classification code 10019819 Term: Hepato-lenticular degeneration System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Trientine dihydrochloride 300mg capsules Pharmaceutical Form: Capsule, hard | UNIVAR LTD | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;Greece;Spain;Germany;United Kingdom;Italy | |||
| 15 | NCT02702765 | February 2016 | 7 October 2019 | sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis | Macrophages and the Macrophage Activation Markers sCD163 and Mannose Receptor (sMR) in Patients With Wilsons Disease - Associations With Liver Disease Severity and Fibrosis | Wilsons Disease | Procedure: Fibroscan;Procedure: Ultrasound;Drug: Galactose;Procedure: Liver biopsy;Procedure: Functional hepatic nitrogen clearance | University of Aarhus | Aarhus University Hospital | Recruiting | 18 Years | 100 Years | All | 33 | N/A | Denmark |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02426905 | January 2016 | 16 December 2017 | 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 | Not recruiting | 1 Year | 90 Years | All | 90 | Phase 4 | Germany;Greece;Italy;United Kingdom | |
| 17 | NCT02273596 | November 24, 2014 | 15 July 2019 | Efficacy and Safety Study of WTX101 in Adult Wilson Disease Patients | A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older With an Extension Phase of 12 Months | Wilson Disease | Drug: WTX101 | Alexion Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 28 | Phase 2 | United States;Austria;Germany;Poland;United Kingdom | |
| 18 | EUCTR2014-001703-41-DE | 18/08/2014 | 28 February 2019 | A clinical trial in adult Wilson Disease Patients to evaluate efficacy and safety of WTX101 following administration for 24 weeks and an extension phase of 36 months. | A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older with an Extension Phase of 36 Months | Wilson Disease MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Code: WTX101 Pharmaceutical Form: Tablet INN or Proposed INN: none CAS Number: 64-9749-10-0 Current Sponsor code: WTX101 Other descriptive name: bis-choline TETRATHIOMOLYBDATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- | Alexion Pharmaceuticals, INC. | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Poland;Austria;Germany;United Kingdom | |||
| 19 | EUCTR2013-003564-31-DE | 27/02/2014 | 27 August 2018 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE CAS Number: 38260-01-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Univar B.V. | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | Germany;Italy | |||
| 20 | NCT01874028 | May 2013 | 19 February 2015 | A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients | A Phase 1 Pharmacokinetic Profiling Study in Patients Receiving Trientine Dihydrochloride for the Treatment of Wilson's Disease. | Wilson's Disease | Drug: trientine dihydrochloride | Univar BV | Aptiv Solutions | Not recruiting | 6 Years | 90 Years | Both | 20 | Phase 1 | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01472874 | January 2010 | 19 October 2017 | Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease | Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease | Wilson Disease | Drug: Once a day Trientine | Yale University | Valeant Pharmaceuticals International, Inc. | Not recruiting | 18 Years | N/A | All | 8 | N/A | United States |
| 22 | NCT00212355 | March 2005 | 29 April 2019 | Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan. | Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan. | Wilson's Disease | Drug: NPC-02 | Nobelpharma | Not recruiting | 1 Year | N/A | All | 37 | Phase 3 | ||
| 23 | NCT00212368 | October 2004 | 19 February 2015 | Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan. | Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan. | Wison's Disease | Drug: Zinc acetate | Nobelpharma | Not recruiting | 1 Year | N/A | Both | Phase 3 | |||
| 24 | NCT00004339 | January 1994 | 19 February 2015 | Study of Tetrathiomolybdate in Patients With Wilson Disease | Wilson Disease | Drug: tetrathiomolybdate;Drug: trientine | National Center for Research Resources (NCRR) | University of Michigan | Not recruiting | N/A | N/A | Both | 90 | Phase 3 | United States | |
| 25 | NCT00004338 | October 1993 | 19 February 2015 | Study of Zinc for Wilson Disease | Wilson Disease | Drug: zinc acetate | National Center for Research Resources (NCRR) | University of Michigan | Not recruiting | N/A | N/A | Both | 300 | Phase 4 | United States |