Initial Study of Rituximab to Treat Primary Biliary Cirrhosis

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT00364819
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Primary Biliary Cirrhosis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jan 31, 2007
Status verified
Jun 2017
Primary completion
Jul 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    rituximab 1000 mg IV on days 1 and 15, given over 5 - 6 hours

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Medical CenterSacramentoCalifornia95817-

Find similar trials in Sacramento, CA

By research site
University of California Davis Medical Center· Sacramento, CA

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