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

  
17 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2017-004135-36-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
2EUCTR2017-004135-36-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
3EUCTR2017-004135-36-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
4EUCTR2017-004135-36-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
5EUCTR2019-000905-57-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
6EUCTR2017-004135-36-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
7EUCTR2017-004135-36-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
8EUCTR2017-004135-36-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
9EUCTR2017-004135-36-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
10EUCTR2017-004135-36-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
11EUCTR2017-004135-36-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
12NCT00212355
(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
13NCT00212368
(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
14NCT00004338
(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
15EUCTR2017-004135-36-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
16EUCTR2017-004135-36-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
17EUCTR2017-004135-36-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