NCT03345589

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

November 6, 2017

Last Update Submit

May 2, 2018

Conditions

Primary Biliary Cholangitis

Keywords

Ursodeoxycholic Acid

Outcome Measures

Primary Outcomes (1)

  • Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)

    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 Outcomes (5)

  • Alkaline phosphatase

    Week 2 and Month 1, 3, 6,9,12

  • Glutamyltransferase

    Week 2 and Month 1, 3, 6,9,12

  • Alanine transaminase

    Week 2 and Month 1, 3, 6

  • Aspartate transaminase

    Week 2 and Month 1, 3, 6, 9,12

  • Total bilirubin

    Week 2 and Month 1, 3, 6, 9,12

Study Arms (2)

18-22mg/kg/d Ursodeoxycholic group

EXPERIMENTAL
Drug: 18-22mg/kg/d Ursodeoxycholic

13-15mg/kg/d Ursodeoxycholic group

PLACEBO COMPARATOR
Drug: 13-15mg/kg/d Ursodeoxycholic

Interventions

18-22mg/kg/d UrsodeoxycholicDRUG

18-22mg/kg/d Ursodeoxycholic

18-22mg/kg/d Ursodeoxycholic group
13-15mg/kg/d UrsodeoxycholicDRUG

13-15mg/kg/d Ursodeoxycholic

13-15mg/kg/d Ursodeoxycholic group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Autoimmune hepatitis
  • Primary sclerosing cholangitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Yang, MD

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Ping Ni, MD

CONTACT

13281091993545043216@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 17, 2017

Study Start

January 30, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

CN(1)