SRL (Sirolimus) Withdrawal

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
Acute Rejection of Liver TransplantEffects of Immunosuppressant Therapy
Interventions
DRUG

Sirolimus

SRL minimization will be performed if clinically, biochemically and histologically stable. Patients entering the minimization phases will be reduced every month by 50% of total dose of Sirolimus until they reach .5mg daily for one month. Then .5 mg every other day, then twice weekly, the once weekly dosing. This should take approximately 6 month to complete minimization. Liver function tests will be monitored every 2 weeks. For any patient developing liver dysfunction, liver biopsy will be performed. Patients will then be completely withdrawn and followed post-withdrawal for 12 months.

Trial Locations (1)

60611

Northwestern University, Chicago

All Listed Sponsors
lead

Northwestern University

OTHER

NCT02062944 - SRL (Sirolimus) Withdrawal | Biotech Hunter | Biotech Hunter