Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
NCT ID: NCT00093093
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
900 participants
INTERVENTIONAL
2004-06-30
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Viramidine
Ribavirin
pegylated interferon alfa-2a
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ralph T. Doyle
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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University of Arizona
Tucson, Arizona, United States
UCSF Fresno- Internal Medicine
Fresno, California, United States
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
University of California Davis Medical Center
Sacramento, California, 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
San Mateo Medical Center
San Mateo, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Bach and Godofsky
Bradenton, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Atlanta Academic Research Group
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Louisiana State University Memorial Hospital
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins
Baltimore, Maryland, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, United States
Maryland Digestive Disease Research
Laurel, Maryland, United States
Future Care Studies/Northgate Medical
Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Bradley Freilich, MD
Kansas City, Missouri, United States
Saint Louis University School of Medicine
St Louis, Missouri, United States
Atlantic Gastroenterology Associates
Egg Harbor, New Jersey, United States
Regional Clinical Research, Inc.
Johnson City, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Cabrini Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Bronx VA Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Digestive Health Specialists
Winston-Salem, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Research Solutions (SMO)
Tulsa, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Radiant Research - Austin
Austin, Texas, United States
University of Texas
Dallas, Texas, United States
VA Medical Center
Houston, Texas, United States
INOVA Fairfax Hospital
Annadale, Virginia, United States
Kaiser Permanente Medical Center
Falls Church, Virginia, United States
Hunter Holmes McGuire Medical Center
Richmond, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Hospital Italiano
Buenos Aires, Buenos Aires, Argentina
Fundación CIDEA
Buenos Aires, Buenos Aires, Argentina
Hospital Británico
Buenos Aires, Buenos Aires, Argentina
Hospital Austral
Pilar, Buenos Aires, Argentina
Hospital Centenario
Rosario, Santa Fe Province, Argentina
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
The Alfred Hospital
Prahran, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
Grenoble, , France
Hopital Saint Joseph Service d'Hépato-gastroentérologie
Marseille, , France
Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
Nice, , France
Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie
Paris, , France
C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
Vandouevre Les Nancy, , France
Rambam Medical Center Liver Unit
Haifa, , Israel
Head of Liver Unit, Holy family Hospital
Nazareth, , Israel
Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
Tel Aviv, , Israel
Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
Busto Arsizio, , Italy
Az. Osp. Universitaria Policlinico "Paolo Giaccone"
Palermo, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
Rome, , Italy
Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
Torino, , Italy
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
Bydgoszcz, , Poland
Szpital Specjalistyczny
Chorzów, , Poland
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
Warsaw, , Poland
Wojewodzki Szpital Zakazny
Warsaw, , Poland
Fundacion de Investigacion de Diego
Santurce, , Puerto Rico
Russian State Medical University
Moscow, , Russia
City Hospital of Infectious Diseases #10
Saint Petersburg, , Russia
Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
Saint Petersburg, , Russia
City Hospital of Infectious Diseases #30
Saint Petersburg, , Russia
Department of infectious diseases, Russian Military Academy
Saint Petersburg, , Russia
Smolensk Medical Academy
Smolensk, , Russia
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Carlos III
Madrid, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
Birmingham, , United Kingdom
Liver Unit, Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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RNA003142-302
Identifier Type: -
Identifier Source: org_study_id
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