At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
rituximabdrug
Likely dose
rituximab 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Rituximab (Rituxan) on B Cell and AMA Response in Patients With Primary Biliary Cirrhosis
In Brief
A Phase 2 clinical trial evaluating rituximab for Primary Biliary Cirrhosis. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cirrhosis
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartJan 2007
Primary CompletionJul 2009
Study CompletionDec 2009
TodayJul 2026
First PostedAug 16, 2006
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.9 years ago
Interventions
rituximabdrug
rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours