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

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ClinicalTrials.gov Identifier: NCT03299829
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Excelsior

Tracking Information
First Submitted Date September 25, 2017
First Posted Date October 3, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date January 10, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 27, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03299829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 27, 2017)
The improvement in urine copper excretion [ Time Frame: Up to 1 year ]
To measure 24-hour urine copper levels during the study period
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
Official Title A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who had the diagnosis of Wilson's disease
Condition Trientine Treatment for Wilson's Disease
Intervention Drug: Trientine
Trientine is a chelating agent for removing the copper from the body
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 27, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kung-Yin Lin, Master +886-2+26557568 ext 662 cliff.lin@excelsiorgroup.com.tw
Contact: Xinyu Huang, Master +886-2-2655-7568 ext 663 tiffany.huang@excelsiorgroup.com.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03299829
Other Study ID Numbers EB-TR-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Excelsior
Study Sponsor Excelsior
Collaborators Not Provided
Investigators
Principal Investigator: Chinchang Huange, Doctor Chang Gung Memorial Hospital
PRS Account Excelsior
Verification Date February 2019