Copper ( DrugBank: Copper )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 1 |
| 169 | メンケス病 | 5 |
| 170 | オクシピタル・ホーン症候群 | 1 |
| 171 | ウィルソン病 | 26 |
2. 筋萎縮性側索硬化症
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| 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 | NCT01259050 (ClinicalTrials.gov) | October 2010 | 10/12/2010 | Safety Study of High Doses of Zinc in ALS Patients | Phase 1 Open Label Study of Zinc Therapy in ALS Patients | Amyotrophic Lateral Sclerosis | Drug: Zinc and Copper | Phoenix Neurological Associates, LTD | NULL | Completed | 18 Years | 85 Years | Both | 10 | Phase 1/Phase 2 | United States |
169. メンケス病
臨床試験数 : 6 / 薬物数 : 6 - (DrugBank : 4) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 14
| 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 | NCT04074512 (ClinicalTrials.gov) | October 15, 2019 | 27/8/2019 | Copper Histidinate Treatment for Menkes Disease | Copper Histidinate Treatment for Menkes Disease | Menkes Disease | Drug: Copper Histidinate | Cyprium Therapeutics, Inc. | NULL | Available | N/A | 6 Years | All | NULL | ||
| 2 | JPRN-UMIN000030626 | 2014/11/28 | 28/12/2017 | Investigation on the effectiveness of histidine copper treatment of Menkes disease patients | Investigation on the effectiveness of histidine copper treatment of Menkes disease patients - Investigation on the effectiveness of histidine copper treatment of Menkes disease patients | Menkes disease | Weekly,subcutaneous injection of histidine copper (750microgram once) is performed three times per week.It is continued every week until the end of the research during the research period. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 2 | Not selected | Japan |
| 3 | JPRN-UMIN000005259 | 2011/03/03 | 18/03/2011 | Clinical trial of histidine-copper and diethyldithiocarbamate combination therapy for patients with Menkes disease | Clinical trial of histidine-copper and diethyldithiocarbamate combination therapy for patients with Menkes disease - Histidine-copper and diethyldithiocarbamate combination therapy for Menkes disease | Menkes disease | give a dose of copper-histidine and diethyldithiocarbamate | Kobe Unniversitu Graduate School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 2 | Not selected | Japan |
| 4 | NCT00811785 (ClinicalTrials.gov) | February 27, 2009 | 18/12/2008 | Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency | Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency | Menkes Disease;Occipital Horn Syndrome;Unexplained Copper Deficiency | Drug: Copper Histidine | Cyprium Therapeutics, Inc. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);National Center for Complementary and Integrative Health (NCCIH) | Completed | N/A | 80 Years | All | 93 | Phase 3 | United States |
| 5 | NCT00001262 (ClinicalTrials.gov) | June 1990 | 3/11/1999 | Copper Histidine Therapy for Menkes Diseases | Early Copper Histidine Therapy in Menkes Disease | Kinky Hair Syndrome | Drug: Copper Histidine | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | N/A | N/A | All | 60 | Phase 1/Phase 2 | United States |
170. オクシピタル・ホーン症候群
臨床試験数 : 2 / 薬物数 : 4 - (DrugBank : 3) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 14
| 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 | NCT00811785 (ClinicalTrials.gov) | February 27, 2009 | 18/12/2008 | Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency | Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency | Menkes Disease;Occipital Horn Syndrome;Unexplained Copper Deficiency | Drug: Copper Histidine | Cyprium Therapeutics, Inc. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);National Center for Complementary and Integrative Health (NCCIH) | Completed | N/A | 80 Years | All | 93 | Phase 3 | United States |
171. ウィルソン病
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 | ChiCTR2200058434 | 2022-04-01 | 2022-04-09 | Prediction of prognosis of Wilson's disease by anti-copper treatment using transfer learning-quantitative MRI intelligent model | The study of migration learning-quantitative MRI intelligent model for predicting the prognosis of neurological Wilson's disease | Wilson's disease | Neuro-WD:Penicillamine, zinc;Hep-WD:Zinc;Control group:None; | The First Affiliated Hospital, Sun Yat-Sen University | NULL | Pending | 10 | 64 | Both | Neuro-WD:60;Hep-WD:60;Control group:60; | Phase 1 | China |
| 2 | EUCTR2020-005266-34-ES (EUCTR) | 11/02/2022 | 06/09/2021 | A study to understand the safety and the effects of a virus that transfers a modified protein responsible for copper metabolism (copper-transporting P-type adenosine triphosphatase, ATP7B) in adults with Wilson disease. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Seamless, Adaptive, Safety, Dose-finding, and Phase 3 Clinical Study of UX701 AAV-mediated Gene Transfer for the Treatment of Wilson Disease - Cyprus2+ | Wilson disease MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: UX701 (5.0 × 10^12 genome copies/kg) INN or Proposed INN: UX701 Other descriptive name: Adeno-associated viral vector serotype 9 encoding human ATP7B Product Name: UX701 (1.0 × 10^13 genome copies/kg) INN or Proposed INN: UX701 Other descriptive name: Adeno-associated viral vector serotype 9 encoding human ATP7B Product Name: UX701 (2.0 × 10^13 genome copies/kg) INN or Proposed INN: UX701 Other descriptive name: Adeno-associated viral vector serotype 9 encoding human ATP7B | Ultragenyx Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Phase 1;Phase 2;Phase 3 | United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Argentina;Brazil;Poland;Germany;Japan | ||
| 3 | EUCTR2020-005832-31-DK (EUCTR) | 13/04/2021 | 01/02/2021 | The effect of ALXN1840 on uptake of copper in the liver as measured by copper PET/CT scan. | Efficacy of ALXN1840 on human hepatic copper uptake quantified with 64CuCl2 PET/CT-scan. - ALXN1840-HV-Cu Absorption | Healthy Volunteers (Wilson's disease) MedDRA version: 22.0;Level: SOC;Classification code 10022891;Term: Investigations;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cuprior 150 mg INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE Other descriptive name: Cuprior Trade Name: Metalcaptase Product Name: Metalcaptase INN or Proposed INN: PENICILLAMINE Product Name: ALXN1840 INN or Proposed INN: ALXN1840 Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | Denmark | ||
| 4 | EUCTR2021-000102-25-DK (EUCTR) | 09/04/2021 | 01/02/2021 | The effect of ALXN1840 on excretion of copper in gall as measured by copper PET/MR-scan. | Efficacy of ALXN1840 on human biliary copper excretion quantified with 64CuCl2 PET/MR-scan - ALXN1840-WD-Cu Excretion | Wilson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALXN1840 INN or Proposed INN: ALXN1840 Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE Product Name: 64CuCl2 INN or Proposed INN: [64Cu]Cl2 Other descriptive name: COPPER (64CU) CHLORIDE | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5 | Phase 2 | Denmark | ||
| 5 | EUCTR2019-003711-60-DE (EUCTR) | 15/01/2021 | 02/06/2020 | A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840 | A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks | Wilson's 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 Product Code: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 6 | NCT04422431 (ClinicalTrials.gov) | December 2, 2020 | 22/5/2020 | Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840 | A Phase 2, Single-arm Pathologist-blinded 48-week Study Using Liver Biopsy Specimens to Assess Copper Concentration and Histopathologic Changes in ALXN1840-treated Patients With Wilson Disease Followed by an up to 48-weeks Extension Period | Wilson Disease | Drug: Bis-Choline Tetrathiomolybdate | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 31 | Phase 2 | United States;Denmark;New Zealand;Russian Federation;Singapore;Spain;United Kingdom;Australia;Austria;Belgium;Canada;Germany;Korea, Republic of;Poland |
| 7 | EUCTR2019-003711-60-FR (EUCTR) | 22/10/2020 | 20/08/2020 | A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840 | A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks | Wilson's 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 Product Code: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 8 | EUCTR2019-003711-60-AT (EUCTR) | 23/09/2020 | 01/10/2020 | A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840 | A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks | Wilson's 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 Product Code: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 9 | NCT04573309 (ClinicalTrials.gov) | September 7, 2020 | 28/9/2020 | Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 | A Phase 2, Open-label Study to Assess Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 | Wilson Disease | Drug: ALXN1840 | Alexion Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 8 | Phase 2 | United States;New Zealand;United Kingdom |
| 10 | EUCTR2019-003711-60-DK (EUCTR) | 27/08/2020 | 19/06/2020 | A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840 | A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks | Wilson's 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 Product Code: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 11 | EUCTR2019-003711-60-GB (EUCTR) | 26/08/2020 | 09/07/2020 | A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840 | A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks | Wilson's 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 Product Code: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 12 | EUCTR2020-001104-41-GB (EUCTR) | 22/07/2020 | 11/06/2020 | Copper Balance in Participants with Wilson Disease Treated with ALXN1840 | A Phase 2, open-label study to assess copper and molybdenum balance in participants with Wilson disease treated with ALXN1840 - Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 | Wilson Disease (WD) 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: ALXN1840 INN or Proposed INN: Not applied Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | United Kingdom | ||
| 13 | ChiCTR2200057544 | 2020-01-01 | 2022-03-14 | Study on treatment and monitoring of Wilson's disease | Quantitative MRI analysis of structural alternation of deep gray matter nucleus in Wilson's disease | Wilson's disease | Cerebral patients group:anti-copper drugs;Liver type patients group:anti-copper drugs;Control group:none; | First Affiliated Hospital of Sun Yat-Sen University | NULL | Recruiting | 10 | 64 | Both | Cerebral patients group:60;Liver type patients group:60;Control group:60; | China | |
| 14 | 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 | ||
| 15 | ChiCTR1900023410 | 2019-06-01 | 2019-05-26 | 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 | NULL | Recruiting | Both | Target condition:40;Difficult condition:20 | China | |||
| 16 | EUCTR2019-000905-57-DK (EUCTR) | 17/04/2019 | 14/03/2019 | Efficacy of zinc on copper uptake in the body depending on zinc type and dose regimen measured with 64CuCl2 PET/CT-scan | Efficacy of zinc on human gut copper uptake depending on zinc type and dose regimen quantified with 64CuCl2 PET/CT-scan | Healthy volunteers (Wilson's disease) MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Wilzin INN or Proposed INN: Zinc acetate Trade Name: Zink Natur-Drogeriet INN or Proposed INN: Zinc gluconate Other descriptive name: ZINC GLUCONATE Product Name: 64CuCl2 INN or Proposed INN: 64CuCl2 Other descriptive name: COPPER (64CU) CHLORIDE | The Department of Hepatology and Gastroenterology, Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 17 | 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 | ||
| 18 | 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 | Orphalan | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;United States;Poland;Belgium;Brazil;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 19 | 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 | ||
| 20 | EUCTR2016-003876-29-AT (EUCTR) | 12/04/2017 | 10/04/2017 | 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] | 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 SA | NULL | Not 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): no | France;Poland;Brazil;Denmark;Austria;Germany;Italy;United Kingdom | ||
| 21 | 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 | ||
| 22 | ChiCTR-DDD-17010552 | 2017-01-25 | 2017-02-04 | 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 | NULL | Recruiting | Both | Target condition:20;Difficult condition:0 | China | |||
| 23 | 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 | ||
| 24 | NCT02763215 (ClinicalTrials.gov) | May 19, 2016 | 3/5/2016 | The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment | Multi-Center Study for the Assessment of Copper Parameters in Wilson Disease Subjects on Standard of Care Treatment | Wilson Disease | Drug: Standard of Care Medications | Alexion Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 64 | United States;Austria;Germany;Poland;United Kingdom | |
| 25 | 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 | ||
| 26 | NCT04965545 (ClinicalTrials.gov) | January 1, 2004 | 5/7/2021 | Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson Disease | Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson Disease | Wilson Disease | Dietary Supplement: low copper diet | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 6 Years | 65 Years | All | 1000 | China |