Trientine Treatment for Wilson's DiseaseNCT03299829
A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
An observational study of Trientine Treatment for Wilson's Disease, run by Excelsior at 1 site in Taiwan.
Trial summary
This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Trientine Treatment for Wilson's Disease
- What is being tested?
- Trientine
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had the diagnosis of Wilson's disease
Who may be able to join
- Diagnosis of Wilson's disease.
- Male or female patients, aged 3 years to 75 years
Who cannot join
- Patients with comorbidity which is not related to Wilson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Trientine Treatment for Wilson's Disease
- Being tested
- Trientine
- Keywords
- trientine, Wilson's disease
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrientineDrug
Trientine is a chelating agent for removing the copper from the body
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Secondary outcomes (1)
The improvement in urine copper excretion
To measure 24-hour urine copper levels during the study period
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start10 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trientine Treatment for Wilson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Excelsior
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chinchang Huange, Doctor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299829
- Sponsor's protocol ID
- EB-TR-001
- Status last verified
- Aug 2020
- First submitted
- 25 Sep 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
- ClinicalTrials.gov ID
- NCT03299829
- Acronym / sponsor ID
- EB-TR-001
- Conditions
- Trientine Treatment for Wilson's Disease
- Keywords
- trientine, Wilson's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ExcelsiorIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had the diagnosis of Wilson's disease
Key inclusion criteria (2 listed)
- Diagnosis of Wilson's disease.
- Male or female patients, aged 3 years to 75 years
Key exclusion criteria (1 listed)
- Patients with comorbidity which is not related to Wilson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrientineTrientine is a chelating agent for removing the copper from the body | Drug | – |
Primary outcome
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
1 secondary outcome
The improvement in urine copper excretion
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Trientine Treatment for Wilson's Disease
RecruitingPhase 3
Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
Wilson's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chinchang Huange, Doctor principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trientine Treatment for Wilson's Disease, run by Excelsior at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement in liver function (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.