EUCTR2013-003564-31-DE
Active, not recruiting
Phase 1
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Prospective Study to Assess Long Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With d-Penicillamine
nivar B.V.0 sites90 target enrollmentOctober 22, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- nivar B.V.
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients aged 1 year to 90 years of age at initiation of treatment with trientine.
- •\- Physician established diagnosis of Wilson disease based on a Ferenci score \> 3 at the date of diagnosis.
- •\- Documented treatment with d\-Penicillamine, withdrawal of treatment with d\- Penicillamine, followed by treatment with trientine for at least 6 months at date of informed consent.
- •\- Able/willing to provide written informed consent.
- •For enrolment in the prospective part:
- •\- Enrolment in the retrospective part of the study.
- •\- On\-going treatment with trientine.
- •\- Negative pregnancy test.
- •\- Able/willing to provide written informed consent.
- •Are the trial subjects under 18? yes
Exclusion Criteria
- •\- Incomplete history of medication use for trientine from initial diagnosis to latest follow up.
- •\- Unavailable outcome data for hepatic and neurological course of disease at initiation of treatment with trientine and at least 1 time point post\-initiation of treatment with trientine.
- •For enrolment in the prospective part:
- •\- Hypersensitivity to trientine
- •\- Severe anaemia.
Outcomes
Primary Outcomes
Not specified
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