Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-07-31

Brief Summary

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A study to review Wilson disease patients who have previously been prescribed d- Penicillamine but were changed to trientine as treatment for their disease, and to follow them for a further 12 months.

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Detailed Description

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A retrospective study to review Wilson disease patients who have previously been prescribed d- Penicillamine but were changed to trientine as treatment for their disease, and to follow them prospectively for a further 12 months.

Conditions

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Wilson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Retrospective

Group Type NO_INTERVENTION

No interventions assigned to this group

Prospective

Group Type OTHER

trientine dihydrochloride

Intervention Type DRUG

A retrospective review of patients' medical records

Interventions

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trientine dihydrochloride

A retrospective review of patients' medical records

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No