Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Hepatitis C
Interventions
DRUG

LADR Treatment

"PEG-Intron (peginterferon alfa-2b (PEGIFN)) Redipen; Rebetol (ribavirin (RBV) United States Pharmacopeia (USP)) Capsules:~Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was \<0.5 ug/kg, PEGIFN was permanently discontinued."

Trial Locations (8)

10032

Columbia University, New York

19104

University of Pennsylvania Hospital, Philadelphia

22908

University of Virginia, Charlottesville

23219

Virginia Commonwealth University, Richmond

60611

Northwestern University Division of Transplantation, Chicago

80262

University of Colorado, Denver

90095-7054

University of California Los Angeles, Los Angeles

94143-0538

University of California San Francisco, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

collaborator

Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH