Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Hepatitis CHepatitis C, ChronicNonimmune Nonviral Causes of Liver Failure
Interventions
DRUG

calcineurin inhibitor-based immunosuppression

May be cyclosporine, mycophenolate mofetil, or tacrolimus

PROCEDURE

liver transplant

Occurs at study entry

DRUG

corticosteroids

3-month course of corticosteroids

OTHER

immunosuppression withdrawal

One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.

Trial Locations (8)

19104

University of Pennsylvania, Philadelphia

44195

Cleveland Clinic, Cleveland

48109

University of Michigan, Ann Arbor

60208

Northwestern University, Chicago

76798

Baylor University, Dallas

80262

University of Colorado, Denver

94143

University of California, San Francisco, San Francisco

98195

University of Washington, Seattle

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00135694 - Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant | Biotech Hunter | Biotech Hunter