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Hepatitis B |
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Clinical Trial: Study of Viramidine to Ribavirin in Patients with Chronic Hepatitis C Who are Treatment Naive
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Chronic Hepatitis C | Drug: Viramidine Drug: Ribavirin Drug: pegylated interferon alfa-2a | Phase III |
MedlinePlus related topics: Hepatitis; Hepatitis C
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitic C
Expected Total Enrollment: 900
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)
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Location and Contact Information
Arizona
University of Arizona, Tucson, Arizona, 85724-5136, United States; Recruiting
Thomas Boyer, MD, Principal Investigator
California
California Pacific Medical Center, San Francisco, California, 94115, United States; Recruiting
Robert Gish, MD, Principal Investigator
San Mateo Medical Center, San Mateo, California, 94403, United States; Recruiting
Joanne Imperial, MD, Principal Investigator
Keck School of Medicine, University of Southern California, Los Angeles, California, 90033, United States; Recruiting
Karen Lindsay, Principal Investigator
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Paul Martin, MD, Principal Investigator
Research and Education, Inc., San Diego, California, 92115, United States; Recruiting
Tuan Nguyen, MD, Principal Investigator
University of California Davis Medical Center, Sacramento, California, 95817, United States; Recruiting
Neville Pimstone, MD, PhD, Principal Investigator
Orange Coast Medical Group, Newport Beach, California, 92633, United States; Recruiting
Jorge Rodriguez, MD, Principal Investigator
UCSF Fresno- Internal Medicine, Fresno, California, 93702, United States; Recruiting
Muhammad Sheikh, MD, Principal Investigator
University of California San Francisco, San Francisco, California, 94143, United States; Recruiting
Norah Terrault, MD, Principal Investigator
Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Greg Everson, MD, Principal Investigator
Rocky Mountain Gastroenterology, Lakewood, Colorado, 80215, United States; Recruiting
John S Goff, MD, Principal Investigator
Connecticut
University of Connecticut, Farmington, Connecticut, 06030, United States; Recruiting
Khalid Aziz, MD, Principal Investigator
District of Columbia
Washington Hospital Center, Washington, District of Columbia, 20010, United States; Recruiting
Averell Sherker, MD, Principal Investigator
Walter Reed Army Medical Center, Washington, District of Columbia, 20307, United States; Recruiting
Maria Sjogren, MD, Principal Investigator
Florida
Mayo Clinic Jacksonville, Jacksonville, Florida, 32216, United States; Recruiting
Rolland Dickson, MD, Principal Investigator
Bach and Godofsky, Bradenton, Florida, 34205, United States; Recruiting
Eliot Godofsky, MD, Principal Investigator
Georgia
Atlanta Gastroenterology Associates, Atlanta, Georgia, 30308, United States; Recruiting
Norman Gitlin, MD, Principal Investigator
Atlanta Academic Research Group, Atlanta, Georgia, 30033, United States; Recruiting
Mark Stern, MD, Principal Investigator
Illinois
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States; Recruiting
Steven Flamm, MD, Principal Investigator
University of Chicago, Chicago, Illinois, 60637, United States; Recruiting
Helen Te, MD, Principal Investigator
Indiana
Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States; Recruiting
Paul Kwo, MD, Principal Investigator
Kentucky
University of Louisville, Louisville, Kentucky, 40202, United States; Recruiting
Craig McClain, MD, Principal Investigator
Louisiana
Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States; Recruiting
Robert Perillo, MD, Principal Investigator
Louisiana State University Memorial Hospital, New Orleans, Louisiana, 70115, United States; Recruiting
Luis Balart, MD, Principal Investigator
Maryland
Maryland Digestive Disease Research, Laurel, Maryland, 20707, United States; Recruiting
Richard Chasen, MD, Principal Investigator
Johns Hopkins University Medical Center, Baltimore, Maryland, 21287, United States; Recruiting
Mark Sulkowski, MD, Principal Investigator
Johns Hopkins, Baltimore, Maryland, 21205, United States; Recruiting
Paul Thuluvath, MD, Principal Investigator
Massachusetts
Future Care Studies/Northgate Medical, Springfield, Massachusetts, 01107, United States; Recruiting
Jose Azocar, MD, Principal Investigator
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01655, United States; Recruiting
Lawton Shick, MD, Principal Investigator
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting
Russell Wiesner, MD, Principal Investigator
Missouri
Saint Louis University School of Medicine, St. Louis, Missouri, 63104, United States; Recruiting
Bruce Bacon, MD, Principal Investigator
Bradley Freilich, MD, Kansas City, Missouri, 64131, United States; Recruiting
Bradley Freilich, MD, Principal Investigator
New Jersey
Atlantic Gastroenterology Associates, Egg Harbor Township, New Jersey, 08234, United States; Recruiting
John Santoro, DO, Principal Investigator
New York
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
David Bernstein, MD, Principal Investigator
Bronx VA Medical Center, Bronx, New York, 10468, United States; Recruiting
Norbert Brau, MD, Principal Investigator
SUNY Upstate Medical University, Syracuse, New York, 13210, United States; Recruiting
Robert Levine, MD, Principal Investigator
Cabrini Medical Center, New York, New York, 10029, United States; Recruiting
Joseph Odin, MD, FACP, Principal Investigator
Jacobi Medical Center, Bronx, New York, 10461, United States; Recruiting
Douglas Simon, MD, Principal Investigator
Regional Clinical Research, Inc., Johnson City, New York, 13790, United States; Recruiting
Leslie Bank, MD, Principal Investigator
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27599, United States; Recruiting
Michael Fried, MD, Principal Investigator
Digestive Health Specialists, Winston Salem, North Carolina, 27103, United States; Recruiting
Gary Poleynard, MD, Principal Investigator
Ohio
Consultants for Clinical Research, Cincinnati, Ohio, 45219, United States; Recruiting
Mark Jonas, MD, Principal Investigator
MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Kevin Mullen, MD, Principal Investigator
Oklahoma
Research Solutions (SMO), Tulsa, Oklahoma, 74104, United States; Recruiting
Harvey Tatum, MD, Principal Investigator
Pennsylvania
Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Victor Navarro, MD, Principal Investigator
Texas
Radiant Research - Austin, Austin, Texas, 78758, United States; Recruiting
Imtiaz Alam, MD, Principal Investigator
University of Texas, Dallas, Texas, 75390, United States; Recruiting
William M Lee, MD, Principal Investigator
VA Medical Center, Houston, Texas, 77030, United States; Recruiting
Borris Yoffe, MD, Principal Investigator
Virginia
Hunter Holmes McGuire Medical Center, Richmond, Virginia, 23249, United States; Recruiting
Anastasios Mihas, MD, Principal Investigator
Kaiser Permanente Medical Center, Falls Church, Virginia, 22046, United States; Recruiting
Robert W Sjogren, MD, Principal Investigator
INOVA Fairfax Hospital, Annadale, Virginia, 22003, United States; Recruiting
Zobair Younossi, MD, MPH, Principal Investigator
Washington
Northwest Medical Specialties, Tacoma, Washington, 98405, United States; Recruiting
David McEniry, MD, Principal Investigator
Argentina, BA
Hospital Británico, Buenos Aires, BA, (C1280AEB), Argentina; Recruiting
Luis Colombato, MD, Principal Investigator
Hospital Italiano, Buenos Aires, BA, (C1199ACK), Argentina; Recruiting
Adrian Gadano, MD, Principal Investigator
Hospital Austral, Pilar, BA, (B1629AHJ), Argentina; Recruiting
Marcelo Silva, MD, Principal Investigator
Fundación CIDEA, Buenos Aires, BA, (C1264AAA), Argentina; Recruiting
Ruben Terg, MD, Principal Investigator
Argentina, Santa Fe
Hospital Centenario, Rosario, Santa Fe, (S2000CFJ), Argentina; Recruiting
Hugo Tanno, MD, Principal Investigator
Australia, New South Wales
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Geoff Farrel, MD, Principal Investigator
Australia, South Australia
Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia; Recruiting
Hugh Harley, MD, Principal Investigator
Australia, Victoria
Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia; Recruiting
Joseph Sasadeusz, MD, Principal Investigator
The Alfred Hospital, Prahran, Victoria, 3181, Australia; Recruiting
Stuart Roberts, MD, Principal Investigator
Australia, Western Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting
Gary Jeffrey, MD, Principal Investigator
Canada, Alberta
University of Alberta, Edmonton, Alberta, T6G 2C8, Canada; Recruiting
Vincent Bain, MD, Principal Investigator
University of Calgary, Calgary, Alberta, T2N 4N1, Canada; Recruiting
Robert Myers, MD, Principal Investigator
Canada, Manitoba
University of Manitoba, Winnipeg, Manitoba, R3E 3P4, Canada; Recruiting
Kelly Kaita, MD, Principal Investigator
Canada, Ontario
Toronto Western Hospital, Toronto, Ontario, M5T 2S8, Canada; Recruiting
Jenny Heathcote, MD, Principal Investigator
France
Hopital Saint Joseph Service d'Hépato-gastroentérologie, Marseille, 13285, France; Recruiting
Marc Bourliere, MD, Principal Investigator
C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie, Vandouevre les Nancy, 54511, France; Recruiting
Jean-Pierre Bronowicki, MD, Principal Investigator
Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie, Paris, 75571, France; Recruiting
Raoul Poupon, MD, Principal Investigator
CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie, Grenoble, 38043, France; Recruiting
Jean-Pierre Zarski, MD, Principal Investigator
Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie, Nice, 06202, France; Recruiting
Albert Tran, MD, Principal Investigator
Israel
Rambam Medical Center Liver Unit, Haifa, 31096, Israel; Recruiting
Yaakov Baruch, MD, Principal Investigator
Head of Liver Unit, Holy family Hospital, Nazareth, 16100, Israel; Recruiting
Riffat Safadi, MD, Principal Investigator
Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology, Tel Aviv, 64239, Israel; Recruiting
Yoav Lurie, MD, Principal Investigator
Italy
Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista, Torino, 20126, Italy; Recruiting
Mario Rizzetto, MD, Principal Investigator
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, Rome, 00149, Italy; Recruiting
Giorgio Antonucci, MD, Principal Investigator
IRCCS Policlinico San Matteo, Pavia, 27100, Italy; Recruiting
Lorenzo Minoli, MD, Principal Investigator
Malattie Infettive, Azienda Ospedaliera di Busto Arsizio, Busto Arsizio, 21052, Italy; Recruiting
Giuliano Rizzardini, MD, Principal Investigator
Az. Osp. Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy; Recruiting
Poland
Szpital Specjalistyczny, Chorzow, 41-500, Poland; Recruiting
Marek Benioski, MD, PhD, Principal Investigator
Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej, Szczecin, 71-455, Poland; Recruiting
Anna Boron-Kaczmarska, PhD, Principal Investigator
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza, Bydgoszcz, 85-030, Poland; Recruiting
Halota Waldemar, PhD, Principal Investigator
Wojewodzki Szpital Zakazny, Warszawa, 01-201, Poland; Recruiting
Horban Andrzej, MD, PhD, Principal Investigator
Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego, Krakow, 31-531, Poland; Recruiting
Mach Tomasz, PhD, Principal Investigator
Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM, Warszawa, 00-909, Poland; Recruiting
Witold Tlustochowicz, PhD, Principal Investigator
Puerto Rico
Fundacion de Investigacion de Diego, Santurce, 00909, Puerto Rico; Recruiting
Maribel Rodriguez-Torres, MD, Principal Investigator
Russian Federation
Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442, St Petersburg, 193163, Russian Federation; Recruiting
Vladimir B Grinevich, PhD, Principal Investigator
City Hospital of Infectious Diseases #10, St Petersburg, 190020, Russian Federation; Recruiting
Elena N Vinogradova, PhD, Principal Investigator
City Hospital of Infectious Diseases #30, St Petersburg, 193167, Russian Federation; Recruiting
Alexey A Yakovlev, PhD, Principal Investigator
Department of infectious diseases, Russian Military Academy, St Petersburg, 194175, Russian Federation; Recruiting
Konstantin V Zhadanov, PhD, Principal Investigator
Smolensk Medical Academy, Smolensk, 214018, Russian Federation; Recruiting
Vladimir V Rafalski, MD, Principal Investigator
Russian State Medical University, Moscow, 115516, Russian Federation; Recruiting
Igor G Nikitin, PhD, Principal Investigator
Spain
Hospital Universitario Germans Trias i Pujol, Badalona, 08916, Spain; Recruiting
Ramon Planas, Badalona, Principal Investigator
Hospital Santa Creu I Sant Pau, Barcelona, 08025, Spain; Recruiting
Jaime Enriquez, MD, Principal Investigator
Hospital Universitario La Princesa, Madrid, 28006, Spain; Recruiting
Ricardo Moreno, MD, Principal Investigator
Hospital Carlos III, Madrid, 28029, Spain; Recruiting
Javier Garcia Sameniego, MD, Principal Investigator
Hospital General Universitario de Valencia, Valencia, 46014, Spain; Recruiting
Mioses Diago, MD, Principal Investigator
United Kingdom
Liver Unit, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, United Kingdom; Recruiting
Peter Hayes, MD, Principal Investigator
Liver and Hepatobiliary Unit, Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom; Recruiting
David Mutimer, MD, Principal Investigator
More Information
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: September 30, 2004
ClinicalTrials.gov Identifier: NCT00093093
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Add Hepatitis B Vaccination to Your Back to School List (National Center for Infectious Diseases, CDC, OPHS, HHS)
- Advice for Parents (Hepatitis B Foundation)

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