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Completed

NCT Number: NCT02078882

Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

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).

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Key information

Conditions

Primary Biliary Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Diabetes Mellitus, Insulin-Dependent, 12 Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univeristy of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Abatacept

Biological

125 mg subcutaneously each week for 24 weeks

Other names: Orencia

Primary outcomes

  1. Biochemical Response

    Time frame: Week 24

    Number of Participants with a decrease of alkaline phosphatase by > 40%of the Day 0 level at 24 weeks of treatment.

Secondary outcomes

  1. Drug Safety

    Time frame: Weeks 2, 4, 12, 24, and 36

    Number of participants with any adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug.

  2. Absolute Change in Alkaline Phosphatase

    Time frame: Week 24

    The absolute change in alkaline phosphatase from Day 0 to Week 24.

  3. Absolute Change in Alanine Transferase (ALT)

    Time frame: Week 24

    The absolute change in alanine transferase (ALT) from Day 0 to Week 24.

  4. 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.

  5. Primary Billiary Cholangitis Quality of Life

    Time frame: Week 24

    Change in quality of life measured by change in primary biliary cholangitis (PBC)-40 from Day 0 to Week 24. is a patient-derived, disease specific quality of life measure developed and validated for use in PBC with subscores for domains of symptoms, itch, fatigue, cognition, social, and emotional. Subdomains are summed with a total score range of 36 to 200. Higher scores indicate worse quality of life.

  6. Percent Change in Alkaline Phosphatase

    Time frame: Week 24

    The percent change in alkaline phosphatase from Day 0 to Week 24.

  7. Percent Change in Alanine Transferase (ALT)

    Time frame: Week 24

    The percent change in alanine transferase (ALT) from Day 0 to Week 24.

Other outcomes

  1. Immunoglobulin M (IgM) Levels

    Time frame: Week 24

    Change in IgM level from Day 0 to Week 24

  2. Memory T Cell Frequencies

    Time frame: Week 24

    Change in cluster of differentiation 4 (CD4)+ cluster of differentiation 44 (CD44)+ cluster of differentiation 62 ligand (CD62L)- and cluster of differentiation 8+ CD44+ CD62L- frequencies in peripheral blood mononuclear cells from Day 0 to Week 24

  3. Abatacept Levels

    Time frame: Day 0 and Weeks 4, 12, 24, and 36

    Trough serum levels of abatacept

Sponsors and collaborators

Lead sponsor

Christopher Bowlus, MD

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: PBC

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2014
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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