PENICILLAMINE ( DrugBank: Penicillamine )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症1
171ウィルソン病25

51. 全身性強皮症


臨床試験数 : 523 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01374282
(ClinicalTrials.gov)
January 201014/6/2011Post Marketing Surveillance Study of CupriminePost Marketing Surveillance Study of Cuprimine (MK-0172-001)SclerodermaDrug: Cuprimine (penicillamine)Merck Sharp & Dohme Corp.NULLNo longer availableN/AN/ABothN/ANULL

171. ウィルソン病


臨床試験数 : 68 薬物数 : 79 - (DrugBank : 17) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 28
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005832-31-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
2EUCTR2017-004135-36-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
3EUCTR2017-004135-36-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
4EUCTR2017-004135-36-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;Sweden;New Zealand;Japan;Germany;Singapore;Poland;Belgium;Brazil;Canada;Hungary;Czech Republic
5EUCTR2017-004135-36-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 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;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
6EUCTR2016-003876-29-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
7NCT03957720
(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
8EUCTR2017-004135-36-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
9NCT03539952
(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: PenicillamineGMP-Orphan SASNULLActive, not recruiting18 Years75 YearsAll55Phase 3United States;Belgium;Brazil;Denmark;France;Germany;Italy;Poland;United Kingdom;Sweden
10EUCTR2017-004135-36-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
11EUCTR2017-004135-36-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
12EUCTR2017-004135-36-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
13EUCTR2017-004135-36-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 3Poland;Singapore;Croatia;Germany;New Zealand;Japan;Sweden;Brazil;Belgium;Canada;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Korea, Democratic People's Republic of;Czechia;Netherlands;Denmark;Australia;France;Colombia;Israel;Russian Federation;Spain;Greece;Taiwan;Hong Kong;Portugal;United States;Serbia
14EUCTR2017-004135-36-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
15EUCTR2016-003876-29-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
16EUCTR2016-003876-29-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
17EUCTR2016-003876-29-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
18EUCTR2016-003876-29-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
19EUCTR2016-003876-29-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
20EUCTR2013-003564-31-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
21NCT02426905
(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
22EUCTR2013-003564-31-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
23EUCTR2017-004135-36-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
24EUCTR2017-004135-36-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
25EUCTR2017-004135-36-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