A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

May 2, 2018 updated by: Li Yang, West China Hospital

A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with primary biliary cholangitis
  • Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid

Exclusion Criteria:

  • Autoimmune hepatitis
  • Primary sclerosing cholangitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 18-22mg/kg/d Ursodeoxycholic group
Drug: 18-22mg/kg/d Ursodeoxycholic
18-22mg/kg/d Ursodeoxycholic
PLACEBO_COMPARATOR: 13-15mg/kg/d Ursodeoxycholic group
Drug: 13-15mg/kg/d Ursodeoxycholic
13-15mg/kg/d Ursodeoxycholic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
Time Frame: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alkaline phosphatase
Time Frame: Week 2 and Month 1, 3, 6,9,12
(ALP)
Week 2 and Month 1, 3, 6,9,12
Glutamyltransferase
Time Frame: Week 2 and Month 1, 3, 6,9,12
(GGT)
Week 2 and Month 1, 3, 6,9,12
Alanine transaminase
Time Frame: Week 2 and Month 1, 3, 6
(ALT)
Week 2 and Month 1, 3, 6
Aspartate transaminase
Time Frame: Week 2 and Month 1, 3, 6, 9,12
(AST)
Week 2 and Month 1, 3, 6, 9,12
Total bilirubin
Time Frame: Week 2 and Month 1, 3, 6, 9,12
(TB)
Week 2 and Month 1, 3, 6, 9,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBC-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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