Triethylenetetramine ( DrugBank: Triethylenetetramine )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
171ウィルソン病4

171. ウィルソン病


臨床試験数 : 79 薬物数 : 77 - (DrugBank : 17) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 30
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004604-33-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
2EUCTR2020-004604-33-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
3EUCTR2020-004604-33-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
4EUCTR2020-004604-33-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