Phase 4
Completed N=16
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Source: ClinicalTrials.gov NCT02078882 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Biochemical Response — 1 Participants
◆ Published Evidence
Emerging
5citations · ~1 / year
Time for the dawn of multimodal therapies and the dusk for mono-therapeutic trials for cholestatic liver diseases?
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).
Linked Publications
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Time for the dawn of multimodal therapies and the dusk for mono-therapeutic trials for cholestatic liver diseases?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemical Response |
1 | — |
| SECONDARY Drug Safety |
4 | — |
| SECONDARY Absolute Change in Alkaline Phosphatase |
-2.8 | — |
| SECONDARY Absolute Change in Alanine Transferase (ALT) |
0.5 | — |
| SECONDARY Liver Stiffness Measured by Magnetic Resonance Elastography |
-0.1 | — |
| SECONDARY Primary Billiary Cholangitis Quality of Life |
— | — |
| SECONDARY Percent Change in Alkaline Phosphatase |
0.01 | — |
| SECONDARY Percent Change in Alanine Transferase (ALT) |
0.01 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02078882) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.