Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02078882
• Date of registration: 03/03/2014
• Prospective Registration: Yes
• Primary sponsor: Christopher Bowlus, MD
• Public title: Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis PBC
• Scientific title: Abatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic Acid
• Date of first enrolment: September 2014
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02078882
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: M. Eric Gershwin, MD
• Affiliation: University of California, Davis

• Name: Christopher L Bowlus, MD
• Affiliation: University of California, Davis

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed PBC diagnosis based upon at least 2 of 3 criteria

1. Anti-mitochondrial antibody (AMA) titer > 1:40

2. Alkaline phosphatase > 1.5 times the upper limit of normal for at least 6 months

3. 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Biological: abatacept

Primary Outcome(s)

Biochemical Response [Time Frame: Week 24]

Secondary Outcome(s)

Percent Change in Alanine Transferase (ALT) [Time Frame: Week 24]

Absolute Change in Alkaline Phosphatase [Time Frame: Week 24]

Primary Billiary Cholangitis Quality of Life [Time Frame: Week 24]

Liver Stiffness Measured by Magnetic Resonance Elastography [Time Frame: Week 24]

Absolute Change in Alanine Transferase (ALT) [Time Frame: Week 24]

Drug Safety [Time Frame: Weeks 2, 4, 12, 24, and 36]

Percent Change in Alkaline Phosphatase [Time Frame: Week 24]

Secondary ID(s)

IM101-457

599969

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

Results

• Results available: Yes
• Date Posted: 30/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02078882