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

Sichuan University

Status and phase: Unknown; Phase 4

Conditions: Primary Biliary Cholangitis

Treatments: Drug: 13-15mg/kg/d Ursodeoxycholic; Drug: 18-22mg/kg/d Ursodeoxycholic

Study type: Interventional

Funder types: Other

Identifiers

NCT03345589

PBC-3

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

18-22mg/kg/d Ursodeoxycholic group

Experimental group

Treatment:

Drug: 18-22mg/kg/d Ursodeoxycholic

13-15mg/kg/d Ursodeoxycholic group

Placebo Comparator group

Treatment:

Drug: 13-15mg/kg/d Ursodeoxycholic