EUCTR2013-003564-31-IT
Active, not recruiting
Phase 1
Multicentre, Retrospective Study to Assess Long-Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn from Therapy With - N/A
IVAR LTD0 sites90 target enrollmentApril 26, 2018
ConditionsWilson disease, also known as hepatolenticular degeneration, a rare automsomal, recessively inherited disorder which results in chronic copper intoxication.MedDRA version: 20.0Level: PTClassification code 10019819Term: Hepato-lenticular degenerationSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Wilson disease, also known as hepatolenticular degeneration, a rare automsomal, recessively inherited disorder which results in chronic copper intoxication.
- Sponsor
- IVAR LTD
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged 1 year to 90 years of age
- •2\. Physician\-established diagnosis of Wilson disease based on a Ferenci score \= 3
- •3\. 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
- •4\. Able/willing to provide written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 23
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1
Exclusion Criteria
- •1\. Incomplete history of medication use for trientine from initial diagnosis to last follow\-up
- •2\. Unavailable outcome data for hepatic and neurological course of disease at all assessment time points
- •3\. Patients with acute liver failure and fulminant hepatic disease with fatal outcome.
Outcomes
Primary Outcomes
Not specified
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