116
Participants
Start Date
March 31, 2009
Primary Completion Date
November 30, 2010
Study Completion Date
November 30, 2011
ribavirin
Co-administered in all arms: oral ribavirin, 200 mg capsules. Subjects with body weight \< 65 kg: 800 mg/day; Subjects with body weight 65-85 kg: 1000 mg/day; Subjects with body weight \> 85 kg: 1200 mg/day.
Locteron™ (controlled-release interferon alpha 2b)
investigational controlled-release recombinant interferon alpha 2b formulated in 1500/77/23 PolyActive microspheres as a lyophilized powder, reconstituted with carboxymethyl cellulose immediately before subcutaneous injection every other week as part of the treatment of chronic hepatitis C
PEG-Intron™
commercially available pegylated interferon alpha 2b injected subcutaneously weekly in a dose of 1.5 ug/kg as part of the treatment of chronic hepatitis C
Tokuda Hospital, Sofia
"UMHAT Alexandrovska", Sofia
"UMHAT St Ivan Rilski", Sofia
"UMHAT Queen Giovanna - ISUL EAD", Sofia
Medical Institute Ministry of Interior, Sofia
Military Medical Academy, Sofia
"UMHAT St Marina", Varna
Montefiore Medical Center, The Bronx
Maryland Digestive Disease Research, LLC, Laurel
Inova Fairfax Hospital, Falls Church
McGuire DVAMC, Richmond
University of Louisville Health Care Outpatient Center, Louisville
Consultants for Clinical Research, Cincinnati
St. Louis University, St Louis
The Liver Institute at Methodist Dallas, Dallas
Alamo Medical Center, San Antonio
eStudy site, Chula Vista
eStudy Site, Oceanside
Medical Associates Research Group, San Diego
"Victor Babes Clinical Hospital Craiova", Craiova
AGA Clinical Research Associates, LLC., Egg Harbor
Fundacion de Investigacion de Diego, Santurce
Institute of Infectious Diseases, Bucharest
Fundeni Clinical Institute, Bucharest
Lead Sponsor
Biolex Therapeutics, Inc.
INDUSTRY