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

NCT ID: NCT03345589

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2019-01-01

Brief Summary

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

Detailed Description

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Conditions

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Primary Biliary Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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18-22mg/kg/d Ursodeoxycholic group

Group Type EXPERIMENTAL

18-22mg/kg/d Ursodeoxycholic

Intervention Type DRUG

18-22mg/kg/d Ursodeoxycholic

13-15mg/kg/d Ursodeoxycholic group

Group Type PLACEBO_COMPARATOR

13-15mg/kg/d Ursodeoxycholic

Intervention Type DRUG

13-15mg/kg/d Ursodeoxycholic

Interventions

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18-22mg/kg/d Ursodeoxycholic

18-22mg/kg/d Ursodeoxycholic

Intervention Type DRUG

13-15mg/kg/d Ursodeoxycholic

13-15mg/kg/d Ursodeoxycholic

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Yang, MD

Role: STUDY_CHAIR

West China Hospital

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ping Ni, MD

Role: CONTACT

13281091993

Facility Contacts

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Li Yang

Role: primary

+8618980601276

Other Identifiers

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PBC-3

Identifier Type: -

Identifier Source: org_study_id

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