Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
About this trial
This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring Primary Biliary Cirrhosis
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 < 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
Sites / Locations
- University of California Davis Medical Center
Arms of the Study
Arm 1
Experimental
1
rituximab 1000 mg IV on days 1 and 15, given over 5 - 6 hours