171. ウィルソン病 Wilson disease Clinical trials / Disease details


臨床試験数 : 79 薬物数 : 77 - (DrugBank : 17) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 30

  
No.TrialIDDate_
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PhaseCountries
1NCT05686564
(ClinicalTrials.gov)
January 30, 20236/1/2023Early Access Program for ALXN1840 in Patients With Wilson DiseaseEarly Access Program for ALXN1840 in Patients With Wilson Disease.Wilson DiseaseDrug: ALXN1840AlexionNULLAvailable3 YearsN/AAllNULL
2NCT05305872
(ClinicalTrials.gov)
January 1, 202324/11/2021Gandouling in the Treatment of Wilson's DiseaseThe First Affiliated Hospital of Anhui University of Traditional Chinese MedicineWilson's DiseaseDrug: GandoulingJun LiNULLNot yet recruiting15 Years85 YearsAll216Phase 4NULL
3ChiCTR2200058434
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
4EUCTR2020-005266-34-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
5ITMCTR2100005333
2021-12-122021-11-26A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of Wilson's diseaseA multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of patients with hepatolenticular degeneration Wilson's diasease2:Zinc gluconate;1:Gandouling;The First Affiliated Hospital of Anhui University of traditional Chinese MedicineNULLPending1585Both2:100;1:100;Phase 1China
6ChiCTR2100053629
2021-12-122021-11-26A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of Wilson's diseaseA multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of patients with hepatolenticular degeneration Wilson's diseaseA group:Gandouling tablet + zinc gluconate simulator;B group:Zinc gluconate + gandouling tablet simulator;The First Affiliated Hospital of Anhui University of Traditional Chinese MedicineNULLPending15BothA group:100;B group:100;China
7EUCTR2021-001015-82-DE
(EUCTR)
26/11/202110/08/2021Phase 3, open-label study of ALXN1840 versus standard of care in pediatric participants with Wilson diseaseA multicenter, randomized, controlled, open-label, rater-blinded study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease. 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
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;United States;Canada;Spain;Poland;Australia;Germany;United Kingdom;Japan;Korea, Republic of
8EUCTR2021-001015-82-ES
(EUCTR)
22/11/202123/08/2021Phase 3, open-label study of ALXN1840 versus standard of care in pediatric participants with Wilson diseaseA multicenter, randomized, controlled, open-label, rater-blinded study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease. 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
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Serbia;United States;Czechia;Spain;Turkey;Austria;Russian Federation
9EUCTR2020-004604-33-PL
(EUCTR)
16/11/202104/06/2021Multicentre, open-label study to investigate the effects Cufence has, the effects the body has on Cufence and the continued safety and efficacy on patients with Wilson DiseaseOpen label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients - TR-004 UNITED Study Wilson Disease
MedDRA version: 22.1;Level: PT;Classification code 10019819;Term: Hepato-lenticular degeneration;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Cufence (trientine dihydrochloride)
Product Name: Cufence (trientine dihydrochloride)
INN or Proposed INN: Triethylenetetramine dihydrochloride
Other descriptive name: Cufence
Univar Solutions, B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4Poland;Denmark;Germany
10EUCTR2020-000963-22-DE
(EUCTR)
18/10/202110/03/2021A clinical trial: treatment of adult Wilson's Disease patients with gene therapyA Phase I/II, Multicenter, Non-randomized, Open Label, Adaptive Design, 5-year Follow-up, Single Dose-escalation Study of VTX-801 in Adult Patients with Wilson’s Disease - GATEWAY clinical trial Wilson's Disease
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: N/A
Product Code: VTX-801
INN or Proposed INN: NA
Other descriptive name: Adeno-associated viral vector serotype 3B encoding shortened human ATP7B
Vivet Therapeutics SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 1;Phase 2United States;Denmark;Germany;United Kingdom
11EUCTR2020-004604-33-DK
(EUCTR)
08/10/202111/03/2021Multicentre, open-label study to investigate the effects Cufence has, the effects the body has on Cufence and the continued safety and efficacy on patients with Wilson DiseaseOpen label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients - TR-004 UNITED Study Wilson Disease
MedDRA version: 22.1;Level: PT;Classification code 10019819;Term: Hepato-lenticular degeneration;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Cufence (trientine dihydrochloride)
Product Name: Cufence (trientine dihydrochloride)
INN or Proposed INN: Triethylenetetramine dihydrochloride
Other descriptive name: Cufence
Univar Solutions, B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4Poland;Denmark;Germany
12NCT05047523
(ClinicalTrials.gov)
October 6, 20219/9/2021Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson DiseaseA Multicenter, Randomized, Controlled, Open-label, Rater-blinded Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson DiseaseWilson DiseaseDrug: ALXN1840;Drug: Standard of CareAlexionNULLRecruiting3 Years17 YearsAll48Phase 3Australia;France;Germany;Japan;Korea, Republic of;Poland;Spain;United Kingdom
13NCT04884815
(ClinicalTrials.gov)
September 27, 20217/5/2021Study of UX701 Gene Transfer for the Treatment of Wilson DiseaseA 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 DiseaseWilson DiseaseGenetic: UX701;Other: Placebo;Drug: oral corticosteroids;Drug: Placebo for oral corticosteroidsUltragenyx Pharmaceutical IncNULLRecruiting18 YearsN/AAll78Phase 1/Phase 2United States;Canada;Spain
14NCT04537377
(ClinicalTrials.gov)
September 3, 202119/8/2020A Phase I/II Study of VTX-801 in Adult Patients With Wilson's DiseaseA Phase I/II, Multicenter, Non-randomized, Open Label, Adaptive Design, 5-year Follow-up, Single Dose-escalation Study of VTX-801 in Adult Patients With Wilson's DiseaseWilson's DiseaseGenetic: VTX-801Vivet Therapeutics SASNULLRecruiting18 Years65 YearsAll16Phase 1/Phase 2United States;Denmark;Germany;United Kingdom
15ChiCTR2100050549
2021-08-232021-08-28Effect of dexmedetomidine on restlessness and postoperative delirium in patients with Wilson's disease after splenectomyEffect of dexmedetomidine on restlessness and postoperative delirium in patients with Wilson's disease after splenectomy Wilson's diseaseControl group:Normal Saline;Experimental group:Dexmedetomidine;The First Affiliated Hospital of Anhui University of Chinese MedicineNULLTemporary halt1658BothControl group:55;Experimental group:55;China
16EUCTR2020-000963-22-DK
(EUCTR)
05/07/202107/05/2021A clinical trial: treatment of adult Wilson's Disease patients with gene therapyA Phase I/II, Multicenter, Non-randomized, Open Label, Adaptive Design, 5-year Follow-up, Single Dose-escalation Study of VTX-801 in AdultPatients with Wilson's Disease - GATEWAY clinical trial Wilson's Disease
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: N/A
Product Code: VTX-801
INN or Proposed INN: N/A
Other descriptive name: Adeno-associated viral vector serotype 3B encoding shortened human ATP7B
Vivet Therapeutics SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 1;Phase 2United States;Denmark;Germany;United Kingdom
17EUCTR2020-005832-31-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
18EUCTR2021-000102-25-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
19EUCTR2020-004604-33-DE
(EUCTR)
23/02/202117/12/2020Multicentre, open-label study to investigate the effects Cufence has, the effects the body has on Cufence and the continued safety and efficacy on patients with Wilson DiseaseOpen label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients - TR-004 UNITED Study Wilson Disease
MedDRA version: 22.1;Level: PT;Classification code 10019819;Term: Hepato-lenticular degeneration;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Cufence (trientine dihydrochloride)
Product Name: Cufence (trientine dihydrochloride)
INN or Proposed INN: Triethylenetetramine dihydrochloride
Other descriptive name: Cufence
Univar Solutions, B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Poland;Denmark;Germany
20EUCTR2019-003711-60-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
21NCT04422431
(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
22EUCTR2019-003711-60-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
23NCT04526210
(ClinicalTrials.gov)
October 21, 202019/8/2020Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy ParticipantsA Phase 1, Randomized, 2-Period, 2-Sequence, Cross-over Study to Determine the Effect of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy ParticipantsWilson DiseaseDrug: ALXN1840;Drug: Bupropion HydrochlorideAlexion PharmaceuticalsNULLCompleted18 Years50 YearsAll54Phase 1United States
24EUCTR2019-003711-60-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
25NCT04573309
(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
26EUCTR2019-003711-60-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
27EUCTR2019-003711-60-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
28EUCTR2020-001104-41-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
29NCT04526197
(ClinicalTrials.gov)
July 8, 202019/8/2020Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.A Phase 1, Randomized, 2-Period, 2-Sequence, Cross-over Study to Determine the Effect of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.Wilson DiseaseDrug: ALXN1840;Drug: CelecoxibAlexion PharmaceuticalsNULLCompleted18 Years50 YearsAll36Phase 1United States
30EUCTR2017-004135-36-NL
(EUCTR)
30/03/202016/10/2019Study 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, IncNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United 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
31EUCTR2017-004135-36-PT
(EUCTR)
13/01/202026/03/2019A 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, IncNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United 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
32ChiCTR2200057544
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
33EUCTR2017-004135-36-SE
(EUCTR)
29/10/201916/04/2019A 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, IncNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;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
34EUCTR2017-004135-36-DK
(EUCTR)
16/10/201905/08/2019A 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 - ALXN1840 Efficacy Safety administered for 48 Weeks Versus SOC in patients with Wilson Disease 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: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE
Trade Name: Penicillamine
INN or Proposed INN: PENICILLAMINE
Trade Name: Trientine dihydrochloride
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
Trade Name: Wilzin
INN or Proposed INN: ZINC ACETATE DIHYDRATE
Alexion Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Israel;Russian Federation;Colombia;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
35EUCTR2016-003876-29-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
36ChiCTR1900023410
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
37EUCTR2019-000905-57-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
38NCT03957720
(ClinicalTrials.gov)
March 15, 20198/4/2019The Individual Therapy for Patients With Wilson's DiseaseThe Individual Therapy for Patients With Wilson's DiseaseWilson's DiseaseDrug: DMPS;Drug: Penicillamine;Drug: DMSA;Drug: Zinc gluconateSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruitingN/AN/AAll400Early Phase 1China
39NCT05641311
(ClinicalTrials.gov)
February 20, 201929/11/2022Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy ParticipantsAn Open-Label, Two-Single Dose, Two-Period, Parallel Group Study to Assess the Pharmacokinetics and Safety of ALXN1840 in Healthy Adult Japanese and Non-Japanese SubjectsWilson DiseaseDrug: ALXN1840Alexion PharmaceuticalsNULLCompleted18 Years45 YearsAll24Phase 1United Kingdom
40NCT04212195
(ClinicalTrials.gov)
December 6, 201818/12/2019Cohort Research on Wilson's DiseaseCohort Research On Wilson's Disease: Genetic Determinants and Biomarker Discovery for Neurological InvolvementWilson's DiseaseGenetic: Next generation sequencing;Diagnostic Test: Imaging and fluid biomarkersUniversity College, LondonNULLRecruiting16 YearsN/AAll500United Kingdom
41EUCTR2017-004135-36-FR
(EUCTR)
14/09/201815/01/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
42NCT03659331
(ClinicalTrials.gov)
September 201828/8/2018A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson DiseaseA Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson DiseaseWilson DiseaseDietary Supplement: ZincProf. Elon PrasNULLUnknown status18 YearsN/AAll50N/ANULL
43NCT03539952
(ClinicalTrials.gov)
June 4, 20184/5/2018Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's DiseaseCHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's DiseaseWilson DiseaseDrug: TETA 4HCL;Drug: PenicillamineOrphalanNULLCompleted18 Years75 YearsAll53Phase 3United States;Belgium;Brazil;Denmark;France;Germany;Italy;Poland;United Kingdom;Sweden
44EUCTR2017-004135-36-ES
(EUCTR)
27/04/201822/01/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 3France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom
45EUCTR2017-004135-36-GB
(EUCTR)
23/03/201819/12/2017A 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
Other descriptive name: ZINC ACETATE DIHYDRATE
Wilson Therapeutics ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
46EUCTR2017-004135-36-DE
(EUCTR)
16/03/201822/12/2017A 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Hong Kong;Taiwan;Greece;Spain;Russian Federation;Israel;Colombia;France;Australia;Denmark;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Hungary;Canada;Belgium;Brazil;Poland;Singapore;Croatia;Germany;New Zealand;Japan;Sweden
47EUCTR2017-004135-36-AT
(EUCTR)
27/02/201817/01/2018A 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Hong Kong;Taiwan;Greece;Spain;Russian Federation;Israel;Colombia;France;Australia;Denmark;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Singapore;Croatia;Germany;New Zealand;Japan;Sweden
48NCT03403205
(ClinicalTrials.gov)
February 15, 201819/12/2017Efficacy and Safety of ALXN1840 (Administered for 48 Weeks Versus Standard of Care in Participants With Wilson DiseaseA 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 OlderWilson DiseaseDrug: ALXN1840;Drug: SoC TherapyAlexion PharmaceuticalsNULLActive, not recruiting12 YearsN/AAll215Phase 3United States;Australia;Austria;Canada;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;New Zealand;Poland;Russian Federation;Serbia;Singapore;Spain;Taiwan;Turkey;United Kingdom;Belgium;Italy
49EUCTR2017-004135-36-HU
(EUCTR)
12/02/201807/02/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 3France;United States;Czech Republic;Hungary;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom
50NCT03299829
(ClinicalTrials.gov)
January 10, 201825/9/2017A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease PatientsA Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease PatientsTrientine Treatment for Wilson's DiseaseDrug: TrientineExcelsiorNULLCompleted3 Years75 YearsAll48Taiwan
51EUCTR2016-003876-29-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
52EUCTR2016-003876-29-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
53EUCTR2016-003876-29-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
54EUCTR2016-003876-29-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
55EUCTR2016-003876-29-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
56ChiCTR-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
57EUCTR2013-003564-31-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
58NCT02763215
(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
59NCT02426905
(ClinicalTrials.gov)
January 201618/9/2014Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-PenicillamineMulticentre, Retrospective and Prospective Study to Assess Long-Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn From Therapy With d-PenicillamineWilson DiseaseDrug: trientine dihydrochlorideUnivar BVNULLActive, not recruiting1 Year90 YearsAll90Phase 4Germany;Greece;Italy;United Kingdom
60EUCTR2014-001703-41-GB
(EUCTR)
11/05/201529/01/2015A clinical trial in adult Wilson Disease Patients to evaluate efficacy and safety of WTX101 following administration for 24 weeks with an Extension Phase of 12 MonthsA 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 Patients to evaluate efficacy and safety of WTX101 Wilson Disease
MedDRA version: 18.1;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850
Product Code: WTX101
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Wilson Therapeutics ABNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;United Kingdom
61EUCTR2014-001703-41-PL
(EUCTR)
22/12/201417/10/2014A 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
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Wilson Therapeutics ABNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Poland;Austria;Germany;United Kingdom
62NCT02273596
(ClinicalTrials.gov)
November 24, 201420/10/2014Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease PatientsA 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 MonthsWilson DiseaseDrug: ALXN1840Alexion PharmaceuticalsNULLCompleted18 YearsN/AAll29Phase 2United States;Austria;Germany;Poland;United Kingdom
63EUCTR2014-001703-41-AT
(EUCTR)
21/08/201424/06/2014A 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
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;United Kingdom
64EUCTR2014-001703-41-DE
(EUCTR)
18/08/201405/06/2014A 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
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Alexion Pharmaceuticals, INC.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;United Kingdom
65EUCTR2013-003564-31-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
66NCT01874028
(ClinicalTrials.gov)
May 20136/6/2013A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease PatientsA Phase 1 Pharmacokinetic Profiling Study in Patients Receiving Trientine Dihydrochloride for the Treatment of Wilson's Disease.Wilson's DiseaseDrug: trientine dihydrochlorideUnivar BVAptiv SolutionsCompleted6 Years90 YearsBoth20Phase 1Germany
67NCT01378182
(ClinicalTrials.gov)
April 201120/6/2011Efficacy of Invitro Expanded Bone Marrow Derived Allogeneic Mesenchymal Stem Cell Transplantation Via Portal Vein or Hepatic Artery or Peripheral Vein in Patients With Wilson CirrhosisEfficacy of Invitro Expanded Bone Marrow Derived Allogeneic Mesenchymal Stem Cell Transplantation Via Portal Vein or Hepatic Artery or Peripheral Vein in Patients With Wilson CirrhosisWilson's DiseaseGenetic: allogeneic mesenchymal stem cell transplantationMurat KantarciogluGulhane Military Medical AcademyCompleted18 Years65 YearsBoth10N/ATurkey
68NCT04965571
(ClinicalTrials.gov)
September 1, 20105/7/2021Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese PatientsClinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese PatientsWilson Disease;Generalized EpilepsyGenetic: genetic testSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLCompletedN/AN/AAll13China
69NCT01472874
(ClinicalTrials.gov)
January 201011/11/2011Single Daily Dosage of Trientine for Maintenance Treatment for Wilson DiseaseSingle Daily Dosage of Trientine for Maintenance Treatment for Wilson DiseaseWilson DiseaseDrug: Once a day TrientineYale UniversityBausch Health Americas, Inc.Completed18 YearsN/AAll8N/AUnited States
70NCT00212355
(ClinicalTrials.gov)
March 200513/9/2005Efficacy 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 DiseaseDrug: NPC-02NobelpharmaNULLCompleted1 YearN/AAll37Phase 3NULL
71NCT00212368
(ClinicalTrials.gov)
October 200413/9/2005Efficacy 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 DiseaseDrug: Zinc acetateNobelpharmaNULLCompleted1 YearN/ABothPhase 3NULL
72NCT04965545
(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
73NCT00004339
(ClinicalTrials.gov)
January 199418/10/1999Study of Tetrathiomolybdate in Patients With Wilson DiseaseWilson DiseaseDrug: tetrathiomolybdate;Drug: trientineNational Center for Research Resources (NCRR)University of MichiganCompletedN/AN/ABoth90Phase 3United States
74NCT00004338
(ClinicalTrials.gov)
October 199318/10/1999Study of Zinc for Wilson DiseaseWilson DiseaseDrug: zinc acetateNational Center for Research Resources (NCRR)University of MichiganCompletedN/AN/ABoth300Phase 4United States
75EUCTR2020-004604-33-FR
(EUCTR)
12/03/2021Multicentre, open-label study to investigate the effects Cufence has, the effects the body has on Cufence and the continued safety and efficacy on patients with Wilson DiseaseOpen label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients - TR-004 UNITED Study Wilson Disease
MedDRA version: 22.1;Level: PT;Classification code 10019819;Term: Hepato-lenticular degeneration;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Cufence (trientine dihydrochloride)
Product Name: Cufence (trientine dihydrochloride)
INN or Proposed INN: Triethylenetetramine dihydrochloride
Other descriptive name: Cufence
Univar Solutions, B.V.NULLNAFemale: yes
Male: yes
50Phase 4France;Poland;Denmark;Germany
76EUCTR2021-001015-82-PL
(EUCTR)
15/09/2021Phase 3, open-label study of ALXN1840 versus standard of care in pediatric participants with Wilson diseaseA multicenter, randomized, controlled, open-label, rater-blinded study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease. 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
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Alexion Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
48Phase 3Serbia;United States;Czechia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
77EUCTR2017-004135-36-CZ
(EUCTR)
09/01/2018A 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- Blinder, Multi-Centre 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;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: ZINC ACETATE DIHYDRATE
Alexion Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Hong Kong;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Singapore;Germany;New Zealand;Japan;Sweden
78EUCTR2017-004135-36-PL
(EUCTR)
03/04/2018A 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, IncNULLNAFemale: yes
Male: yes
180Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Russian Federation;Israel;Colombia;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Belgium;Singapore;Croatia;Germany;New Zealand;Japan;Sweden
79EUCTR2017-004135-36-BE
(EUCTR)
17/06/2019A 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, IncNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United 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