Initial Study of Rituximab to Treat Primary Biliary Cirrhosis

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

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 < 1.2)

Exclusion Criteria:

• End-stage/decompensated liver disease

• ascites

• jaundice with serum bilirubin > 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