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 171. ウィルソン病 [臨床試験数:25,薬物数:29(DrugBank:15),標的遺伝子数:0,標的パスウェイ数:0] 

Searched query = "Wilson disease"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR19000234102019-06-0127 May 2019The 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 diseaseWilson’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 HospitalRecruitingBothTarget condition:40;Difficult condition:20Phase 0China
2NCT03957720March 15, 20193 June 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 UniversityRecruitingN/AN/AAll400Early Phase 1China
3NCT03659331September 201817 September 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 PrasNot recruiting18 YearsN/AAll50N/A
4NCT03539952June 4, 20184 November 2019Trientine 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: PenicillamineGMP-Orphan SASRecruiting18 Years75 YearsAll55Phase 3United States;Belgium;Brazil;Denmark;France;Germany;Italy;Poland;Sweden;United Kingdom
5EUCTR2017-004135-36-ES27/04/201818 June 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 MonthsWilson Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]Product Name: WTX101
Product Code: WTX101
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applied
CAS Number: 649749-10-0
Current Sponsor code: WTX101
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical Form: Tablet
INN or Proposed INN: PENICILLAMINE
CAS Number: 52-67-5
Pharmaceutical Form: Capsule
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
CAS Number: 38260-01-4
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 1.2-2.4-(4-8 capsules)
Pharmaceutical Form: Capsule
INN or Proposed INN: ZINC ACETATE DIHYDRATE
CAS Number: 5970-45-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 150-3 times daily
Wilson Therapeutics ABAuthorisedFemale: yes
Male: yes
102Phase 3France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004135-36-DE16/03/201823 July 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 MonthsWilson Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]Product Name: WTX101
Product Code: WTX101
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applied
CAS Number: 649749-10-0
Current Sponsor code: WTX101
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical Form: Tablet
INN or Proposed INN: PENICILLAMINE
CAS Number: 52-67-5
Pharmaceutical Form: Capsule
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
CAS Number: 38260-01-4
Pharmaceutical Form: Capsule
INN or Proposed INN: ZINC ACETATE DIHYDRATE
CAS Number: 5970-45-6
Wilson Therapeutics ABAuthorisedFemale: yes
Male: yes
102Phase 3France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom
7EUCTR2017-004135-36-AT27/02/20185 March 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 MonthsWilson Disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]Product Name: WTX101
Product Code: WTX101
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applied
CAS Number: 649749-10-0
Current Sponsor code: WTX101
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical Form: Tablet
INN or Proposed INN: PENICILLAMINE
CAS Number: 52-67-5
Pharmaceutical Form: Capsule
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
CAS Number: 38260-01-4
Pharmaceutical Form: Capsule
INN or Proposed INN: ZINC ACETATE DIHYDRATE
CAS Number: 5970-45-6
Wilson Therapeutics ABAuthorisedFemale: yes
Male: yes
102Phase 3France;United States;Hungary;Czech Republic;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom
8NCT03403205February 15, 201811 November 2019Efficacy and Safety of ALXN1840 (Formerly Named WTX101) Administered for 48 Weeks Versus Standard of Care in Patients With Wilson Disease With an Extension Period of up to 60 MonthsA 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 MonthsWilson DiseaseDrug: ALXN1840;Drug: SoC TherapyAlexion PharmaceuticalsRecruiting12 YearsN/AAll180Phase 3United States;Australia;Austria;Czechia;France;Germany;Hungary;Israel;Japan;Poland;Russian Federation;Serbia;Spain;United Kingdom;Italy
9EUCTR2017-004135-36-HU12/02/201826 February 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 MonthsWilson Disease
MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: WTX101
Product Code: WTX101
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applied
CAS Number: 649749-10-0
Current Sponsor code: WTX101
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical Form: Tablet
INN or Proposed INN: PENICILLAMINE
CAS Number: 52-67-5
Pharmaceutical Form: Capsule
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
CAS Number: 38260-01-4
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 1.2-2.4-(4-8 capsules)
Pharmaceutical Form: Capsule
INN or Proposed INN: ZINC ACETATE DIHYDRATE
CAS Number: 5970-45-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 150-3 times daily
Wilson Therapeutics ABAuthorisedFemale: yes
Male: yes
102Phase 3France;United States;Czech Republic;Hungary;Poland;Spain;Austria;Israel;Germany;Italy;United Kingdom
10NCT03299829January 10, 201825 February 2019A 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: TrientineExcelsiorRecruiting3 Years75 YearsAll50Phase 2Taiwan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-003876-29-DK16/05/201728 February 2019Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s diseaseWilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Cuprior 150 mg film-coated tablets
Product Name: TETA.4HCl
Product Code: TETA.4HCl
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Trientine tetrahydrochloride
CAS Number: 4961-40-4
Current Sponsor code: TETA 4HCl
Other descriptive name: TETA 4HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: D-penicillamine
CAS Number: 52-67-5
Other descriptive name: D-penicillamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: D-penicillamine
CAS Number: 52-67-5
Other descriptive name: D-penicillamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: penicillamine
CAS Number: 52-67-5
Other descriptive name: penicillamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: penicillamine
CAS Number: 52-67-5
Other descriptive name: penicillamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
gmp-orphan SAAuthorised Female: yes
Male: yes
55Phase 3Sweden;Italy;United Kingdom;Germany;Denmark;Austria;Belgium;Brazil;Poland;United States;France
12EUCTR2016-003876-29-AT12/04/201728 February 2019Chelate Study: Trientine for the treatment of Wilson's diseaseCHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s diseaseWilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: TETA 4HCl
Product Code: TETA 4HCl
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Trientine tetrahydrochloride
CAS Number: 4961-40-4
Current Sponsor code: TETA 4HCl
Other descriptive name: TETA 4HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical Form: Capsule
INN or Proposed INN: penicillamine
CAS Number: 52-67-5
Other descriptive name: penicillamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical Form: Capsule
INN or Proposed INN: penicillamine
CAS Number: 52-67-5
Other descriptive name: penicillamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
gmp-orphan SANot Recruiting Female: yes
Male: yes
55Phase 3France;Poland;Brazil;Denmark;Austria;Germany;Italy;United Kingdom
13ChiCTR-DDD-170105522017-01-2518 April 2017Genetic diagnosis of Wilson's diseaseGenetic diagnosis of Wilson's diseaseWilson 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 HospitalRecruitingBothTarget condition:20;Difficult condition:0Diagnostic New Technique Clincal StudyChina
14EUCTR2013-003564-31-IT14/07/201630 April 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/AWilson disease, also known as hepatolenticular degeneration, a rare automsomal, recessively inherited disorder which results in chronic copper intoxication.
MedDRA version: 20.0 Level: PT Classification code 10019819 Term: Hepato-lenticular degeneration System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Trientine dihydrochloride 300mg capsules
Pharmaceutical Form: Capsule, hard
UNIVAR LTDNot RecruitingFemale: yes
Male: yes
90Phase 2France;Greece;Spain;Germany;United Kingdom;Italy
15NCT02702765February 20167 October 2019sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and FibrosisMacrophages and the Macrophage Activation Markers sCD163 and Mannose Receptor (sMR) in Patients With Wilsons Disease - Associations With Liver Disease Severity and FibrosisWilsons DiseaseProcedure: Fibroscan;Procedure: Ultrasound;Drug: Galactose;Procedure: Liver biopsy;Procedure: Functional hepatic nitrogen clearanceUniversity of AarhusAarhus University HospitalRecruiting18 Years100 YearsAll33N/ADenmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02426905January 201616 December 2017Study 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 BVNot recruiting1 Year90 YearsAll90Phase 4Germany;Greece;Italy;United Kingdom
17NCT02273596November 24, 201415 July 2019Efficacy and Safety Study of WTX101 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 12 MonthsWilson DiseaseDrug: WTX101Alexion PharmaceuticalsNot recruiting18 YearsN/AAll28Phase 2United States;Austria;Germany;Poland;United Kingdom
18EUCTR2014-001703-41-DE18/08/201428 February 2019A 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 MonthsWilson Disease
MedDRA version: 20.0 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: WTX101
Pharmaceutical Form: Tablet
INN or Proposed INN: none
CAS Number: 64-9749-10-0
Current Sponsor code: WTX101
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Alexion Pharmaceuticals, INC.Not Recruiting Female: yes
Male: yes
30Phase 2United States;Poland;Austria;Germany;United Kingdom
19EUCTR2013-003564-31-DE27/02/201427 August 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 and Prospective Study to Assess Long Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With d-PenicillamineWilson disease, also known as hepatolenticular degeneration, a rare automsomal, recessively inherited disorder which results in chronic copper intoxication.
MedDRA version: 19.1 Level: LLT Classification code 10047988 Term: Wilson's disease System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Trientine dihydrochloride 300mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
CAS Number: 38260-01-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Univar B.V.Not RecruitingFemale: yes
Male: yes
90Phase 4Germany;Italy
20NCT01874028May 201319 February 2015A 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 SolutionsNot recruiting6 Years90 YearsBoth20Phase 1Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01472874January 201019 October 2017Single 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 UniversityValeant Pharmaceuticals International, Inc.Not recruiting18 YearsN/AAll8N/AUnited States
22NCT00212355March 200529 April 2019Efficacy 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-02NobelpharmaNot recruiting1 YearN/AAll37Phase 3
23NCT00212368October 200419 February 2015Efficacy 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 acetateNobelpharmaNot recruiting1 YearN/ABothPhase 3
24NCT00004339January 199419 February 2015Study of Tetrathiomolybdate in Patients With Wilson DiseaseWilson DiseaseDrug: tetrathiomolybdate;Drug: trientineNational Center for Research Resources (NCRR)University of MichiganNot recruitingN/AN/ABoth90Phase 3United States
25NCT00004338October 199319 February 2015Study of Zinc for Wilson DiseaseWilson DiseaseDrug: zinc acetateNational Center for Research Resources (NCRR)University of MichiganNot recruitingN/AN/ABoth300Phase 4United States

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