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A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03299829
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : February 12, 2019
Information provided by (Responsible Party):

Brief Summary:
This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients

Condition or disease Intervention/treatment
Trientine Treatment for Wilson's Disease Drug: Trientine

Detailed Description:
In this retrospective study, the investigators will collect and analyze data from reviewing medical history files of larger and long-term follow-up cohorts with Wilson's disease in Taiwan to assess the efficacy and safety of Trientine in Taiwanese Wilson's Disease patients.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wilson Disease

Intervention Details:
  • Drug: Trientine
    Trientine is a chelating agent for removing the copper from the body

Primary Outcome Measures :
  1. The improvement in liver function [ Time Frame: Up to 1 year ]
    To measure the AST (aspartate aminotransferase), ALT (alanine transaminase), GGT (gamma-glutamyl transpeptidase), Albumin, and Bilirubin level, and compare to the baseline

Secondary Outcome Measures :
  1. The improvement in urine copper excretion [ Time Frame: Up to 1 year ]
    To measure 24-hour urine copper levels during the study period

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had the diagnosis of Wilson's disease

Inclusion Criteria:

  • Diagnosis of Wilson's disease.
  • Male or female patients, aged 3 years to 75 years

Exclusion Criteria:

  • Patients with comorbidity which is not related to Wilson's disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03299829

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Contact: Kung-Yin Lin, Master +886-2+26557568 ext 662
Contact: Xinyu Huang, Master +886-2-2655-7568 ext 663

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Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan City, Taiwan, 333
Contact: Xinyu Huang, Master    +886-2-2655-7568 ext 663   
Contact: Lijun Chen, Bachelor    +886-989-684025   
Sponsors and Collaborators
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Principal Investigator: Chinchang Huange, Doctor Chang Gung Memorial Hospital

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Responsible Party: Excelsior Identifier: NCT03299829     History of Changes
Other Study ID Numbers: EB-TR-001
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Excelsior:
Wilson's disease

Additional relevant MeSH terms:
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Liver Diseases
Hepatolenticular Degeneration
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Metabolic Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action