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Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis — PBC  

Primary Biliary Cirrhosis Clinical Trial

Official title:
Abatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic Acid

Clinical Trial Summary

The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).

Clinical Trial Description

This is an open label, active treatment trial to assess the efficacy and safety of abatacept in subject with PBC who have had an incomplete biochemical response to UDCA. In this trial, 20 subjects with PBC who have had an incomplete biochemical response to UDCA will be assigned to treatment with weekly subcutaneous injections of 125 mg of abatacept. The treatment phase of the study will last 24 weeks with an off-treatment follow up at Week 36.

Inclusion criteria include:

- Confirmed diagnosis of PBC

- Alkaline phosphatase > 1.67 times the upper limit of normal after 6 months of treatment with UDCA ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02078882
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 4
Start date September 2014
Completion date October 2018
View Details
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