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

Trientine Treatment for Wilson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299829
• Other study ID #: EB-TR-001
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2020
• Source: Excelsior
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trientine Treatment for Wilson's Disease

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Excelsior

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement in liver function	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	The improvement in urine copper excretion	To measure 24-hour urine copper levels during the study period	Up to 1 year