Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00093093
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.
- Detailed Description
Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- Treatment-naive patients with compensated chronic hepatitis C.
- HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Pregnant or breast-feeding patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period. - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
- Secondary Outcome Measures
Name Time Method - Efficacy: Undetectable plasma HCV RNA at treatment week 24 - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24 - Safety: Monitoring of adverse events - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Trial Locations
- Locations (100)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
Johns Hopkins University Medical Center
🇺🇸Baltimore, Maryland, United States
University of Texas
🇺🇸Dallas, Texas, United States
Radiant Research - Austin
🇺🇸Austin, Texas, United States
INOVA Fairfax Hospital
🇺🇸Annadale, Virginia, United States
Saint Louis University School of Medicine
🇺🇸St. Louis, Missouri, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Future Care Studies/Northgate Medical
🇺🇸Springfield, Massachusetts, United States
Kaiser Permanente Medical Center
🇺🇸Falls Church, Virginia, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Hunter Holmes McGuire Medical Center
🇺🇸Richmond, Virginia, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Hospital Italiano
🇦🇷Buenos Aires, BA, Argentina
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Louisiana State University Memorial Hospital
🇺🇸New Orleans, Louisiana, United States
Bradley Freilich, MD
🇺🇸Kansas City, Missouri, United States
Research Solutions (SMO)
🇺🇸Tulsa, Oklahoma, United States
Bronx VA Medical Center
🇺🇸Bronx, New York, United States
Maryland Digestive Disease Research
🇺🇸Laurel, Maryland, United States
Regional Clinical Research, Inc.
🇺🇸Johnson City, New York, United States
Atlanta Academic Research Group
🇺🇸Atlanta, Georgia, United States
Liver Unit, Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Hospital Carlos III
🇪🇸Madrid, Spain
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Research and Education, Inc.
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Keck School of Medicine, University of Southern California
🇺🇸Los Angeles, California, United States
UCSF Fresno- Internal Medicine
🇺🇸Fresno, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
San Mateo Medical Center
🇺🇸San Mateo, California, United States
Orange Coast Medical Group
🇺🇸Newport Beach, California, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Connecticut
🇺🇸Farmington, Connecticut, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Atlantic Gastroenterology Associates
🇺🇸Egg Harbor Township, New Jersey, United States
Cabrini Medical Center
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Fundación CIDEA
🇦🇷Buenos Aires, BA, Argentina
Hospital Centenario
🇦🇷Rosario, Santa Fe, Argentina
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Hospital Británico
🇦🇷Buenos Aires, BA, Argentina
Hospital Austral
🇦🇷Pilar, BA, Argentina
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
The Alfred Hospital
🇦🇺Prahran, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
🇫🇷Grenoble, France
Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie
🇫🇷Paris, France
Hopital Saint Joseph Service d'Hépato-gastroentérologie
🇫🇷Marseille, France
Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
🇫🇷Nice, France
C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
🇫🇷Vandouevre les Nancy, France
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Head of Liver Unit, Holy family Hospital
🇮🇱Nazareth, Israel
Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
🇮🇹Busto Arsizio, Italy
Az. Osp. Universitaria Policlinico "Paolo Giaccone"
🇮🇹Palermo, Italy
Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
🇮🇱Tel Aviv, Israel
Rambam Medical Center Liver Unit
🇮🇱Haifa, Israel
Szpital Specjalistyczny
🇵🇱Chorzow, Poland
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
🇵🇱Bydgoszcz, Poland
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
🇮🇹Rome, Italy
Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
🇮🇹Torino, Italy
Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego
🇵🇱Krakow, Poland
Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej
🇵🇱Szczecin, Poland
Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM
🇵🇱Warszawa, Poland
Russian State Medical University
🇷🇺Moscow, Russian Federation
Wojewodzki Szpital Zakazny
🇵🇱Warszawa, Poland
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
City Hospital of Infectious Diseases #10
🇷🇺St.Petersburg, Russian Federation
Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
🇷🇺St.Petersburg, Russian Federation
Smolensk Medical Academy
🇷🇺Smolensk, Russian Federation
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Spain
Department of infectious diseases, Russian Military Academy
🇷🇺St.Petersburg, Russian Federation
City Hospital of Infectious Diseases #30
🇷🇺St.Petersburg, Russian Federation
VA Medical Center
🇺🇸Houston, Texas, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States