B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

March 31, 2016

Study Completion Date

September 30, 2016

Conditions
FatiguePrimary Biliary Cirrhosis
Interventions
BIOLOGICAL

Rituximab

The Rituximab dosing regimen identified is that used in the proof of concept study, which is also the established treatment regimen for Rituximab use in rheumatoid arthritis. All interventions will be administered with a clinician present throughout the infusion in participants who have been encouraged to have adequate oral hydration in the 24 hours prior to attendance. Resuscitation equipment will be immediately available during the infusion period. Blood pressure, heart rate and temperature will be monitored during the infusion. Participants will continue to be observed in the Clinical Research Facility for at least 1 hour after the infusion.

OTHER

Placebo

Participants will be randomised to Rituximab therapy (1000 mg IV on day 1 and 15) or placebo (0.9% Sodium Chloride 250 mls) control

Trial Locations (1)

NE2 4AE

Newcastle Clinical Trials Unit, Newcastle upon Tyne

All Listed Sponsors
collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

collaborator

Department of Health, United Kingdom

OTHER_GOV

collaborator

Newcastle University

OTHER

lead

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

NCT02376335 - B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis | Biotech Hunter | Biotech Hunter