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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01259050
(ClinicalTrials.gov)
October 201010/12/2010Safety Study of High Doses of Zinc in ALS PatientsPhase 1 Open Label Study of Zinc Therapy in ALS PatientsAmyotrophic Lateral SclerosisDrug: Zinc and CopperPhoenix Neurological Associates, LTDNULLCompleted18 Years85 YearsBoth10Phase 1/Phase 2United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04074512
(ClinicalTrials.gov)
October 15, 201927/8/2019Copper Histidinate Treatment for Menkes DiseaseCopper Histidinate Treatment for Menkes DiseaseMenkes DiseaseDrug: Copper HistidinateCyprium Therapeutics, Inc.NULLAvailableN/A6 YearsAllNULL
2JPRN-UMIN000030626
2014/11/2828/12/2017Investigation on the effectiveness of histidine copper treatment of Menkes disease patientsInvestigation on the effectiveness of histidine copper treatment of Menkes disease patients - Investigation on the effectiveness of histidine copper treatment of Menkes disease patients Menkes diseaseWeekly,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 MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female2Not selectedJapan
3JPRN-UMIN000005259
2011/03/0318/03/2011Clinical trial of histidine-copper and diethyldithiocarbamate combination therapy for patients with Menkes diseaseClinical trial of histidine-copper and diethyldithiocarbamate combination therapy for patients with Menkes disease - Histidine-copper and diethyldithiocarbamate combination therapy for Menkes disease Menkes diseasegive a dose of copper-histidine and diethyldithiocarbamateKobe Unniversitu Graduate School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female2Not selectedJapan
4NCT00811785
(ClinicalTrials.gov)
February 27, 200918/12/2008Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper DeficiencyMolecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper DeficiencyMenkes Disease;Occipital Horn Syndrome;Unexplained Copper DeficiencyDrug: Copper HistidineCyprium Therapeutics, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);National Center for Complementary and Integrative Health (NCCIH)CompletedN/A80 YearsAll93Phase 3United States
5NCT00001262
(ClinicalTrials.gov)
June 19903/11/1999Copper Histidine Therapy for Menkes DiseasesEarly Copper Histidine Therapy in Menkes DiseaseKinky Hair SyndromeDrug: Copper HistidineEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompletedN/AN/AAll60Phase 1/Phase 2United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00811785
(ClinicalTrials.gov)
February 27, 200918/12/2008Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper DeficiencyMolecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper DeficiencyMenkes Disease;Occipital Horn Syndrome;Unexplained Copper DeficiencyDrug: Copper HistidineCyprium Therapeutics, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);National Center for Complementary and Integrative Health (NCCIH)CompletedN/A80 YearsAll93Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2200058434
2022-04-012022-04-09Prediction of prognosis of Wilson's disease by anti-copper treatment using transfer learning-quantitative MRI intelligent modelThe study of migration learning-quantitative MRI intelligent model for predicting the prognosis of neurological Wilson's disease Wilson's diseaseNeuro-WD:Penicillamine, zinc;Hep-WD:Zinc;Control group:None;The First Affiliated Hospital, Sun Yat-Sen UniversityNULLPending1064BothNeuro-WD:60;Hep-WD:60;Control group:60;Phase 1China
2EUCTR2020-005266-34-ES
(EUCTR)
11/02/202206/09/2021A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
94Phase 1;Phase 2;Phase 3United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Argentina;Brazil;Poland;Germany;Japan
3EUCTR2020-005832-31-DK
(EUCTR)
13/04/202101/02/2021The 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2Denmark
4EUCTR2021-000102-25-DK
(EUCTR)
09/04/202101/02/2021The 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 2Denmark
5EUCTR2019-003711-60-DE
(EUCTR)
15/01/202102/06/2020A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840A 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
6NCT04422431
(ClinicalTrials.gov)
December 2, 202022/5/2020Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840A 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 PeriodWilson DiseaseDrug: Bis-Choline TetrathiomolybdateAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll31Phase 2United States;Denmark;New Zealand;Russian Federation;Singapore;Spain;United Kingdom;Australia;Austria;Belgium;Canada;Germany;Korea, Republic of;Poland
7EUCTR2019-003711-60-FR
(EUCTR)
22/10/202020/08/2020A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840A 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
8EUCTR2019-003711-60-AT
(EUCTR)
23/09/202001/10/2020A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840A 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, IncNULLNot RecruitingFemale: yes
Male: yes
28Phase 2United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
9NCT04573309
(ClinicalTrials.gov)
September 7, 202028/9/2020Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840A Phase 2, Open-label Study to Assess Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840Wilson DiseaseDrug: ALXN1840Alexion PharmaceuticalsNULLCompleted18 YearsN/AAll8Phase 2United States;New Zealand;United Kingdom
10EUCTR2019-003711-60-DK
(EUCTR)
27/08/202019/06/2020A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840A 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of
11EUCTR2019-003711-60-GB
(EUCTR)
26/08/202009/07/2020A Phase 2 clinical study to assess copper levels and liver changes in patients with Wilson disease who are treated with ALXN1840A 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2United States;Serbia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
12EUCTR2020-001104-41-GB
(EUCTR)
22/07/202011/06/2020Copper Balance in Participants with Wilson Disease Treated with ALXN1840A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2United Kingdom
13ChiCTR2200057544
2020-01-012022-03-14Study on treatment and monitoring of Wilson's diseaseQuantitative MRI analysis of structural alternation of deep gray matter nucleus in Wilson's disease Wilson's diseaseCerebral patients group:anti-copper drugs;Liver type patients group:anti-copper drugs;Control group:none;First Affiliated Hospital of Sun Yat-Sen UniversityNULLRecruiting1064BothCerebral patients group:60;Liver type patients group:60;Control group:60;China
14EUCTR2016-003876-29-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
15ChiCTR1900023410
2019-06-012019-05-26The application of quantitative susceptibility mapping and blood and urine cell culture in Wilson's diseaseThe application of quantitative susceptibility mapping and blood and urine cell culture in Wilson's disease Wilson’s diseaseGold 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 HospitalNULLRecruitingBothTarget condition:40;Difficult condition:20China
16EUCTR2019-000905-57-DK
(EUCTR)
17/04/201914/03/2019Efficacy of zinc on copper uptake in the body depending on zinc type and dose regimen measured with 64CuCl2 PET/CT-scanEfficacy 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Denmark
17EUCTR2016-003876-29-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
18EUCTR2016-003876-29-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
19EUCTR2016-003876-29-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
20EUCTR2016-003876-29-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
21EUCTR2016-003876-29-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
22ChiCTR-DDD-17010552
2017-01-252017-02-04Genetic diagnosis of Wilson's diseaseGenetic diagnosis of Wilson's disease Wilson DiseaseGold 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 HospitalNULLRecruitingBothTarget condition:20;Difficult condition:0China
23EUCTR2013-003564-31-IT
(EUCTR)
14/07/201626/04/2018A 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 capsulesUNIVAR LTDNULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;Greece;Spain;Germany;United Kingdom;Italy
24NCT02763215
(ClinicalTrials.gov)
May 19, 20163/5/2016The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care TreatmentMulti-Center Study for the Assessment of Copper Parameters in Wilson Disease Subjects on Standard of Care TreatmentWilson DiseaseDrug: Standard of Care MedicationsAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll64United States;Austria;Germany;Poland;United Kingdom
25EUCTR2013-003564-31-DE
(EUCTR)
27/02/201422/10/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
90Phase 4Germany;Italy
26NCT04965545
(ClinicalTrials.gov)
January 1, 20045/7/2021Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson DiseaseRole for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson DiseaseWilson DiseaseDietary Supplement: low copper dietSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting6 Years65 YearsAll1000China