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CompletedNCT03299829Updated Aug 18, 2020

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

An observational study in Trientine Treatment for Wilson's Disease, sponsored by Excelsior. Completed at 1 site in Taiwan. Open to participants aged 3 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Excelsior · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48
Ages
3 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Trientine Treatment for Wilson's Disease

Keywords

  • trientine
  • Wilson's disease
03

In context

Hepatolenticular Degeneration

80 studies on the registry are indexed under Hepatolenticular Degeneration; 31 are open to participants now.

This study's enrollment of 48 is below the median of 72 across 35 observational studies indexed under Hepatolenticular Degeneration.

Browse Hepatolenticular Degeneration studies →

Lead sponsor

Excelsior is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who had the diagnosis of Wilson's disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with comorbidity which is not related to Wilson's disease.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48 participants (actual)
Patient registry
No

Interventions

  • DrugTrientine

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

06

What researchers measure

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

    Time frame: Up to 1 year

Secondary outcomes

  1. The improvement in urine copper excretion

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

    Time frame: Up to 1 year

07

Study locations

1 site
  • Chang Gung Memorial Hospital, Linkou
    Taoyuan City, 333, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Jun 2019, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2017
First posted
Oct 3, 2017
StartActual
Jan 10, 2018
Primary completionActual
Jun 30, 2019
CompletionActual
Dec 30, 2019
Last update
Aug 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03299829
Lead sponsor
Excelsior
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Jan 10, 2018
Primary completion
Jun 30, 2019
Completion
Dec 30, 2019
Last update
Aug 18, 2020

Study contacts

Chinchang Huange, Doctor
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Excelsior

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