79
Participants
Start Date
September 30, 2005
Primary Completion Date
December 31, 2009
Study Completion Date
December 31, 2009
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."
Columbia University, New York
University of Pennsylvania Hospital, Philadelphia
University of Virginia, Charlottesville
Virginia Commonwealth University, Richmond
Northwestern University Division of Transplantation, Chicago
University of Colorado, Denver
University of California Los Angeles, Los Angeles
University of California San Francisco, San Francisco
Collaborators (1)
Schering-Plough
INDUSTRY
Ortho Biotech Clinical Affairs, L.L.C.
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH