171. ウィルソン病
［臨床試験数：50，薬物数：59（DrugBank：17），標的遺伝子数：3，標的パスウェイ数：28］
Searched query = "Wilson 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.
| 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 | EUCTR2017-004135-36-NL (EUCTR) | 30/03/2020 | 16/10/2019 | Study to Evaluate the Efficacy and Safety of ALXN1840 in pPtients with Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Colombia;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Germany;Japan;New Zealand;Sweden | ||
| 2 | EUCTR2017-004135-36-PT (EUCTR) | 13/01/2020 | 26/03/2019 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of ALXN1840 in adult and adolescent patients who suffer from Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Hong Kong;Taiwan;Spain;Israel;Russian Federation;Colombia;France;Denmark;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||
| 3 | EUCTR2017-004135-36-SE (EUCTR) | 29/10/2019 | 16/04/2019 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of ALXN1840 in adult and adolescent patients who suffer from Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Russian Federation;Israel;Colombia;France;Australia;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||
| 4 | EUCTR2017-004135-36-DK (EUCTR) | 16/10/2019 | 05/08/2019 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of ALXN1840 in adult and adolescent patients who suffer from Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Russian Federation;Israel;Colombia;France;Australia;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||
| 5 | 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 | gmp-orphan SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;France;Poland;Brazil;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 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 |
| 6 | NCT03957720 (ClinicalTrials.gov) | March 15, 2019 | 8/4/2019 | 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 | NULL | Recruiting | N/A | N/A | All | 400 | Early Phase 1 | China |
| 7 | NCT03539952 (ClinicalTrials.gov) | June 4, 2018 | 4/5/2018 | 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 | NULL | Active, not recruiting | 18 Years | 75 Years | All | 55 | Phase 3 | United States;Belgium;Brazil;Denmark;France;Germany;Italy;Poland;United Kingdom;Sweden |
| 8 | EUCTR2017-004135-36-ES (EUCTR) | 27/04/2018 | 22/01/2018 | 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 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Wilson Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 3 | France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2017-004135-36-DE (EUCTR) | 16/03/2018 | 22/12/2017 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of WTX101 in adult patients who suffer from Wilson Disease. | 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 18 Years And Older With An Extension Period 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Israel;Russian Federation;Colombia;France;Denmark;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||
| 10 | EUCTR2017-004135-36-AT (EUCTR) | 27/02/2018 | 17/01/2018 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of WTX101 in adult and adolescent patients who suffer from Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Colombia;France;Denmark;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Germany;Japan;New Zealand;Sweden | ||
| 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 |
| 11 | EUCTR2017-004135-36-HU (EUCTR) | 12/02/2018 | 07/02/2018 | 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 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Wilson Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 3 | France;United States;Czech Republic;Hungary;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom | ||
| 12 | 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 | ||
| 13 | EUCTR2016-003876-29-DE (EUCTR) | 15/09/2017 | 03/04/2017 | Chelate Study: Trientine for the treatment of Wilson's disease | CHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease | 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 | gmp-orphan SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | Brazil;Belgium;Denmark;Austria;Germany;United Kingdom;United States;France;Poland;Italy;Sweden | ||
| 14 | 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 | gmp-orphan SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;France;Poland;Brazil;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 15 | 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 | ||
| 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 |
| 16 | EUCTR2013-003564-31-IT (EUCTR) | 14/07/2016 | 26/04/2018 | 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 | UNIVAR LTD | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;Greece;Spain;Germany;United Kingdom;Italy | ||
| 17 | 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 |
| 18 | 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 | ||
| 19 | EUCTR2017-004135-36-BE (EUCTR) | 17/06/2019 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of ALXN1840 in adult and adolescent patients who suffer from Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Colombia;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Germany;Japan;New Zealand;Sweden | |||
| 20 | EUCTR2017-004135-36-PL (EUCTR) | 03/04/2018 | A Phase 3 clinical study to Evaluate the Efficacy and Safety of ALXN1840 in adult and adolescent patients who suffer from Wilson Disease. | 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 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE INN or Proposed INN: PENICILLAMINE INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE INN or Proposed INN: ZINC ACETATE DIHYDRATE | Alexion Pharmaceuticals, Inc | NULL | NA | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Colombia;France;Denmark;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Germany;Japan;New Zealand;Sweden |