NCT03299829

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

September 25, 2017

Last Update Submit

August 17, 2020

Conditions

Trientine Treatment for Wilson's Disease

Keywords

trientineWilson's disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The improvement in urine copper excretion

    Up to 1 year

Interventions

TrientineDRUG

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

Eligibility Criteria

Age3 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had the diagnosis of Wilson's disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Hepatolenticular Degeneration

Interventions

Trientine

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic Chemicals

Study Officials

  • Chinchang Huange, Doctor

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 3, 2017

Study Start

January 10, 2018

Primary Completion

June 30, 2019

Study Completion

December 30, 2019

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)