Phase 2
N=6
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT00364819 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 1; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Davis
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
1; 3; 2 | — |
| SECONDARY Change in Serum Immunoglobulin G |
167 | — |
| SECONDARY Change in Serum Immunoglobulin A |
36.8 | — |
| SECONDARY Change in Serum Immunoglobulin M |
121 | — |
| SECONDARY Change in Serum Alkaline Phosphatase |
55.8 | — |
Summary
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must first be established.
Eligibility Criteria
Inclusion Criteria
- Liver biopsy showing histological PBC stages I, II, or III
- Presence of all criteria for the diagnosis of PBC
- serum AMA at titer >1:40
- alkaline phosphatase >2X normal value for >6 months
- compatible liver histology
- Incomplete response to UDCA after 6 months of treatment.
- Negative pregnancy test (female patients in fertile age)
- Adequate renal function (serum creatinine 2mg/dl
- history of digestive bleeding secondary to portal hypertension or endoscopic evidence of varices at stage F2
- history of hepatic encephalopathy
- INR>1.2
- Other coexisting causes of liver disease
- Use of other immunosuppressive medications 4 weeks prior to enrollment
- Diuretics use
Data sourced from ClinicalTrials.gov (NCT00364819). 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.