Primary Biliary Cholangitis Clinical Trial
Official title:
A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Verified date | May 2018 |
Source | West China Hospital |
Contact | Ping Ni, MD |
Phone | 13281091993 |
545043216[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Alkaline phosphatase | (ALP) | Week 2 and Month 1, 3, 6,9,12 | |
Secondary | Glutamyltransferase | (GGT) | Week 2 and Month 1, 3, 6,9,12 | |
Secondary | Alanine transaminase | (ALT) | Week 2 and Month 1, 3, 6 | |
Secondary | Aspartate transaminase | (AST) | Week 2 and Month 1, 3, 6, 9,12 | |
Secondary | Total bilirubin | (TB) | Week 2 and Month 1, 3, 6, 9,12 |
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