114
Participants
Start Date
January 31, 2011
Primary Completion Date
September 30, 2011
Study Completion Date
October 31, 2011
CTS-1027
Supplied in 30mg, 10mg, or 5mg tablets (depending on dose arm) taken twice daily for up to 48 weeks.
pegylated interferon
180 micrograms in 0.5 ml of solution subcutaneously (SQ), delivered in single use syringes administered once per week, for up to 48 weeks.
Ribavirin
200 mg capsules of ribavirn taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg
Placebo
"Tablets identical in appearance to CTS-1027 containing inactive ingredients.~Placebo arm patients: Two tablets taken twice daily, for a total daily dose of four tablets.~30 mg CTS-1027 patients: One tablet taken twice daily, for a total daily dose of two tablets. One bottle of placebo is added to the 30mg kits in order to maintain the study blind (all patients recieve two-bottle kits of CTS-1027 and/or placebo)."
Concorde Medical Group, New York
New York University, New York
Weill Medical College of Cornell, New York
Columbia Presbyterian Medical Center, New York
Einstein College of Medicine (Jacobi Medical Center), The Bronx
New York Medical College, Valhalla
Albert Einstein Medical Center, Philadelphia
Metropolitan Research Group Washington DC, Fairfax
Virginia Commonwealth University (VCU), Richmond
Liver Institute of Virginia, Newport News
Duke University Medical Center, Durham
Atlanta Medical Center, Inc., Atlanta
Liver Center of Atlanta, Atlanta
University of Miami, Miami
University of Alabama at Birmingham, Birmingham
University of Louisville, Louisville
Cleveland Clinic, Cleveland
Consultants for Clinical Research, Cincinnati
Indiana University School of Medicine, Indianapolis
Mayo Clinic, Rochester
Loyola University, Maywood
Rush University Medical Center, Chicago
St. Louis University, St Louis
University of Kansas Medical Center, Kansas City
Tulane University Health Sciences Center, New Orleans
Ochsner Clinic Foundation, New Orleans
Baylor All Saints Medical Center, Fort Worth
Research Specialists of Texas, Houston
St. Luke's Episcopal Hospital, Houston
University of Texas HSC at Houston, Houston
VAMC Houston, Houston
University of Texas Medical Branch at Galveston, Galveston
University of Colorado Denver, Aurora
University of Utah, Salt Lake City
Huntington Medical Research Institute, Pasadena
Scripps Clinic, La Jolla
Southern California Liver Centers, Coronado
Medical Associates Research Group, San Diego
UCSD, San Diego
Loma Linda University MC, Loma Linda
Benaroya Research Institute at Virginia Mason, Seattle
Yale University School of Medicine, New Haven
Beth Israel Deaconess Medical Center, Boston
University of Massachusetts Memorial Medical Center, Worcester
Henry Ford Hospital, Detroit
Lead Sponsor
Conatus Pharmaceuticals Inc.
INDUSTRY