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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02426905
Date of registration: 18/09/2014
Prospective Registration: Yes
Primary sponsor: Univar BV
Public title: Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine
Scientific title: 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Prospective Study to Assess Long-Term Outcomes of Chelator-Based Treatment With Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine
Date of first enrolment: January 2016
Target sample size: 90
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02426905
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Germany Greece Italy United Kingdom
Contacts
Name:     Karl-Heinz Weiss, MD
Address: 
Telephone:
Email:
Affiliation:  Universit√§tsklinik Heidelberg
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients aged 1 year to 90 years of age.

- Physician established diagnosis of Wilson disease based on a Ferenci score > 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.

- Able/willing to provide written informed consent.

- For enrolment in the prospective part, enrolment in the retrospective part of the
study is required.

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 assessment
time points.

- Patients with acute liver failure and fulminant hepatic disease with fatal outcome.

- Hypersensitivity to trientine and severe anaemia.



Age minimum: 1 Year
Age maximum: 90 Years
Gender: All
Health Condition(s) or Problem(s) studied
Wilson Disease
Intervention(s)
Drug: trientine dihydrochloride
Primary Outcome(s)
Clinical outcome specific to the prospective part of the study [Time Frame: 12 months]
Clinical outcome specific to the retrospective part of the study [Time Frame: 48 months]
Secondary Outcome(s)
Quality of Life Endpoints for the Prospective Part of the Study [Time Frame: 12 months]
Safety Endpoint Applicable to both the Retrospective and Prospective Parts of the Study [Time Frame: Up to 60 months]
Secondary ID(s)
UNV-TRI-002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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