Status:
COMPLETED
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Primary Biliary Cirrhosis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 us...
Detailed Description
This is a pilot, open-label, study on 10 female patients with AMA-positive PBC to determine the effects of two infusions of rituximab on response of memory B cells to bacterial motifs, on biochemical ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00364819
Start Date
January 1 2007
End Date
December 1 2009
Last Update
July 2 2017
Active Locations (1)
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1
University of California Davis Medical Center
Sacramento, California, United States, 95817