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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02078882
Other study ID # 599969
Secondary ID IM101-457
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2014
Est. completion date October 2018

Study information

Verified date March 2020
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
abatacept
125 mg subcutaneously each week for 24 weeks

Locations

Country Name City State
United States Univeristy of California Davis Medical Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Christopher Bowlus, MD Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Immunoglobulin M (IgM) Levels Change in IgM level from Day 0 to Week 24 Week 24
Other Memory T Cell Frequencies 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 Week 24
Other Abatacept Levels Trough serum levels of abatacept Day 0 and Weeks 4, 12, 24, and 36
Primary Biochemical Response Number of Participants with a decrease of alkaline phosphatase by > 40%of the Day 0 level at 24 weeks of treatment. Week 24
Secondary Drug Safety Number of participants with any adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug. Weeks 2, 4, 12, 24, and 36
Secondary Absolute Change in Alkaline Phosphatase The absolute change in alkaline phosphatase from Day 0 to Week 24. Week 24
Secondary Absolute Change in Alanine Transferase (ALT) The absolute change in alanine transferase (ALT) from Day 0 to Week 24. Week 24
Secondary Liver Stiffness Measured by Magnetic Resonance Elastography Change in liver stiffness measured by magnetic resonance elastography from Day 0 to Week 24. Week 24
Secondary Primary Billiary Cholangitis Quality of Life 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. Week 24
Secondary Percent Change in Alkaline Phosphatase The percent change in alkaline phosphatase from Day 0 to Week 24. Week 24
Secondary Percent Change in Alanine Transferase (ALT) The percent change in alanine transferase (ALT) from Day 0 to Week 24. Week 24
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