NCT02078882

Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Christopher Bowlus, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	abatacept	125 mg subcutaneously each week for 24 weeks

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2014-03-05
• Last updated: 2020-04-09
• Results posted: 2020-03-30

Locations

1 site across 1 country: United States