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

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

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Key information

Conditions

Trientine Treatment for Wilson's Disease Basal Ganglia Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Hepatolenticular Degeneration Heredodegenerative Disorders, Nervous System Liver Diseases Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases

Age range

3 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital, Linkou

Taoyuan City, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trientine

Drug

Trientine is a chelating agent for removing the copper from the body

Primary outcomes

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 outcomes

The improvement in urine copper excretion

Time frame: Up to 1 year

To measure 24-hour urine copper levels during the study period

Sponsors and collaborators

Lead sponsor

Excelsior

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 3, 2017
Registry last updated: Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed