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

August 17, 2020 updated by: Excelsior
This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had the diagnosis of Wilson's disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement in urine copper excretion
Time Frame: Up to 1 year
To measure 24-hour urine copper levels during the study period
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Excelsior

Investigators

  • Principal Investigator: Chinchang Huange, Doctor, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2018

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

December 30, 2019

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (ACTUAL)

October 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB-TR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trientine Treatment for Wilson's Disease

Clinical Trials on Trientine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe