Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

Completed · Phase 4

Conditions studied: Primary Biliary Cirrhosis

In brief

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).

Key facts

Study ID

NCT02078882

Run by

Christopher Bowlus, MD

People needed

16

Starts

2014-09-01

Expected to finish

2018-10-01

Last updated by the study team

2020-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed PBC diagnosis based upon at least 2 of 3 criteria
• Anti-mitochondrial antibody (AMA) titer > 1:40
• Alkaline phosphatase > 1.5 times the upper limit of normal for at least 6 months
• Liver biopsy findings consistent with PBC
• Incomplete response to UDCA defined by an alkaline phosphatase > 1.67 X the upper limit of normal after 6 months of UDCA at a minimum dose of 13 mg/kg/d
• Taking a stable dose of UDCA for at least 3 months prior to Day 0
• aspartate aminotransferase (AST) and alanine aminotransferase ALT < 5 times the upper limit of normal

You may not qualify if…

• Presence of concomitant liver diseases including viral hepatitis, primary sclerosing cholangitis, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
• Prior liver transplantation
• Decompensated liver disease
• Use of immunosuppressants within 6 months of Day 0
• Use of biologic agents within 12 months of Day 0

Where it is running

• Univeristy of California Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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