Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis (PBC)
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|ClinicalTrials.gov Identifier: NCT02078882|
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : March 30, 2020
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Primary Biliary Cirrhosis||Biological: abatacept||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic Acid|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Experimental: Abatacept 125 mg weekly
Open label treatment with Abatacept
125 mg subcutaneously each week for 24 weeks
Other Name: Orencia
- 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.
- 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.
- Absolute Change in Alkaline Phosphatase [ Time Frame: Week 24 ]The absolute change in alkaline phosphatase from Day 0 to Week 24.
- Absolute Change in Alanine Transferase (ALT) [ Time Frame: Week 24 ]The absolute 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.
- 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.
- Percent Change in Alkaline Phosphatase [ Time Frame: Week 24 ]The percent change in alkaline phosphatase from Day 0 to Week 24.
- Percent Change in Alanine Transferase (ALT) [ Time Frame: Week 24 ]The percent change in alanine transferase (ALT) from Day 0 to Week 24.
- Immunoglobulin M (IgM) Levels [ Time Frame: Week 24 ]Change in IgM level from Day 0 to Week 24
- 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
- Abatacept Levels [ Time Frame: Day 0 and Weeks 4, 12, 24, and 36 ]Trough serum levels of abatacept
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078882
|United States, California|
|Univeristy of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Christopher L Bowlus, MD||University of California, Davis|
|Principal Investigator:||M. Eric Gershwin, MD||University of California, Davis|