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

Primary Biliary Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03345589
• Other study ID #: PBC-3
• Status: Recruiting
• Phase: Phase 4
• Start date: January 30, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2018
• Source: West China Hospital
• Contact: Ping Ni, MD
• Phone: 13281091993
• Email: 545043216[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

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