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Initial Study of Rituximab to Treat Primary Biliary Cirrhosis

NCT00364819 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-07-02

Study results available
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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.

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

rituximab

rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • M. Eric Gershwin, MD · University of California, Davis

  • Christopher L Bowlus, MD · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-07-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00364819 on ClinicalTrials.gov