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

Phase 4UnknownNCT03345589

West China Hospital40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Biliary Cholangitis

Interventions

18-22mg/kg/d UrsodeoxycholicDRUG

18-22mg/kg/d Ursodeoxycholic

13-15mg/kg/d UrsodeoxycholicDRUG

13-15mg/kg/d Ursodeoxycholic

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid

Secondary Outcomes

Alkaline phosphatase

(ALP)

Time frame: Week 2 and Month 1, 3, 6,9,12

Glutamyltransferase

(GGT)

Time frame: Week 2 and Month 1, 3, 6,9,12

Alanine transaminase

(ALT)

Time frame: Week 2 and Month 1, 3, 6

Aspartate transaminase

(AST)

Time frame: Week 2 and Month 1, 3, 6, 9,12

Total bilirubin

(TB)

Time frame: Week 2 and Month 1, 3, 6, 9,12

Central Contacts

Ping Ni, MD

CONTACT

13281091993 545043216@qq.com

Data from ClinicalTrials.gov

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