A Retrospective Study to Assess the Clinical Efficacy and... | NCT03299829

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

NCT03299829

Sponsor

Excelsior

Status

Completed

Last Update Posted

Aug 18, 2020Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Trientine Treatment for Wilson's Disease

Interventions

Trientine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Sep 25, 2017

First Submission Date that Met QC Criteria

Sep 27, 2017

First Posted Date

Oct 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2020

Last Update Posted Date

Aug 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trientine	Drug	Trientine is a chelating agent for removing the copper from the body

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The improvement in urine copper excretion	To measure 24-hour urine copper levels during the study period	Up to 1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who had the diagnosis of Wilson's disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chinchang Huange, Doctor	Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital, Linkou		Taoyuan City		333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006527	Hepatolenticular Degeneration

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D001480	Basal Ganglia Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014266	Trientine

Ancestor Terms

ID	Term
D005029	Ethylenediamines
D003959	Diamines
D011073	Polyamines
D000588	Amines
D009930

Browse Leaves

Not provided

Browse Branches

Not provided