40
Participants
Start Date
September 30, 2009
Primary Completion Date
January 31, 2011
Study Completion Date
January 31, 2011
SCV-07
"SCV-07 dosage will remain the same throughout the study for each cohort. Monotherapy Lead-in Phase Treatment (SCV-07) for 4 weeks. Combination Treatment (SCV-07 and ribavirin) for 4 weeks, following Lead-in Phase. Re-treatment with peg INF and RBV will be offered in the Follow-up to patients who in the opinion of the investigator may benefit from treatment. All patients will have a total of 3 follow-up visits for safety assessments. Women of childbearing potential will be followed up monthly for approximately up to 6 months after the end of treatment visit. If pregnancy occurs within the follow-up period, it needs to be followed through 8 weeks after the end of pregnancy."
Washington Hospital Center-MedStar Research Institute, Washington D.C.
Walter Reed Army Medical Center, Washington D.C.
Paul Thuluvath, Baltimore
Duke University Department of Medicine, Durham
Atlanta Gastroenterology Associates, Atlanta
University of Miami School of Medicine, Miami
Vanderbilt Medical Center, Nashville
University of Louisville, Louisville
Commonwealth Biomedical Research, LLC, Madisonville
University of Cincinnati Medical Center, Cincinnati
Arapahoe Gastroenterology, Littleton
Impact Clinical Trials, Los Angeles
A Professional Corporation, Palm Springs
AGMG Clinical Research, Anaheim
Baylor College of Medicine (VAMC 15), Houston
Kaiser Permanente, Falls Church
Lead Sponsor
SciClone Pharmaceuticals
INDUSTRY