Clinical Trial: Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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

Sponsor: University of California, Davis

Current Primary Outcome: Biochemical Response [ Time Frame: Week 24 ]

Normalization of alkaline phosphatase or decrease of alkaline phosphatase by > 40% of the Day 0 level at 24 weeks of treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety [ Time Frame: Weeks 2, 4, 12, 24, and 36 ]
    Safety outcomes include adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug.
  • Absolute and percent change in alkaline phosphatase [ Time Frame: Week 24 ]
    The absolute and percent change in alkaline phosphatase from Day 0 to Week 24.
  • Absolute and percent change in alanine transferase (ALT) [ Time Frame: Week 24 ]
    The absolute and percent change in alanine transferase (ALT) from Day 0 to Week 24.
  • Liver stiffness measured by magnetic resonance elastography [ Time Frame: Week 24 ]
    Change in liver stiffness measured by magnetic resonance elastography from Day 0 to Week 24.
  • Quality of life [ Time Frame: Week 24 ]
    Change in quality of life measured by change in PBC-40 from Day 0 to Week 24.
  • Anti-abatacept titers [ Time Frame: Week 24 ]
    Frequency and titer of anti-abatacept antibody at Day 0 and Week 24
  • Abatacept levels [ Time Frame: Weeks 0, 4, 12, 24, and 36 ]
    Trough levels of abatacept at Day 0 and Weeks 4, 12, 24, and 36.


Original Secondary Outcome: Same as current

Information By: University of California, Davis

Dates:
Date Received: March 3, 2014
Date Started: September 2014
Date Completion: December 2017
Last Updated: November 23, 2016
Last Verified: November 2016