Cufence (trientine dihydrochloride) ( DrugBank: Trientine )
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-004604-33-PL (EUCTR) | 16/11/2021 | 04/06/2021 | Multicentre, 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 Disease | Open 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | Poland;Denmark;Germany | ||
| 2 | EUCTR2020-004604-33-DK (EUCTR) | 08/10/2021 | 11/03/2021 | Multicentre, 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 Disease | Open 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | Poland;Denmark;Germany | ||
| 3 | EUCTR2020-004604-33-DE (EUCTR) | 23/02/2021 | 17/12/2020 | Multicentre, 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 Disease | Open 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Poland;Denmark;Germany | ||
| 4 | EUCTR2020-004604-33-FR (EUCTR) | 12/03/2021 | Multicentre, 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 Disease | Open 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. | NULL | NA | Female: yes Male: yes | 50 | Phase 4 | France;Poland;Denmark;Germany |