Initial Study of Rituximab to Treat Primary Biliary Cirrhosis

Completed · Phase 1/Phase 2

Conditions studied: Primary Biliary Cirrhosis

In brief

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.

Key facts

Study ID

NCT00364819

Run by

University of California, Davis

People needed

6

Starts

2007-01-01

Expected to finish

2009-12-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of California Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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