Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine

Sponsor
Univar BV
Study ID
NCT02426905
Phase
PHASE4
Status
Unknown

Conditions

  • Wilson Disease

Eligibility Criteria

Sex
ALL
Age
1 Year - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 27, 2015
Start date
Jan 31, 2016
Status verified
Aug 2017
Primary completion
May 31, 2018
Completion
Jul 31, 2018

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Retrospective
  • Other: Prospective

Primary Outcome Measure

Clinical outcome specific to the retrospective part of the study [ Time Frame: 48 months ]

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