Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive (VISER2)

June 21, 2012 updated by: Bausch Health Americas, Inc.

Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

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.

Study Overview

Status

Completed

Conditions

Intervention / 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)

Study Type

Interventional

Enrollment

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • BA
      • Buenos Aires, BA, Argentina, (C1199ACK)
        • Hospital Italiano
      • Buenos Aires, BA, Argentina, (C1264AAA)
        • Fundacion Cidea
      • Buenos Aires, BA, Argentina, (C1280AEB)
        • Hospital Británico
      • Pilar, BA, Argentina, (B1629AHJ)
        • Hospital Austral
    • Santa Fe
      • Rosario, Santa Fe, Argentina, (S2000CFJ)
        • Hospital Centenario
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Prahran, Victoria, Australia, 3181
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • University of Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
  • France
      • Grenoble, France, 38043
        • CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
      • Marseille, France, 13285
        • Hopital Saint Joseph Service d'Hépato-gastroentérologie
      • Nice, France, 06202
        • Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
      • Paris, France, 75571
        • Hôpital Saint Antoine, Service d'hépato-Gastroentérologie
      • Vandouevre les Nancy, France, 54511
        • C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center Liver Unit
      • Nazareth, Israel, 16100
        • Head of Liver Unit, Holy family Hospital
      • Tel Aviv, Israel, 64239
        • Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
  • Italy
      • Busto Arsizio, Italy, 21052
        • Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
      • Palermo, Italy, 90127
        • Az. Osp. Universitaria Policlinico "Paolo Giaccone"
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo
      • Rome, Italy, 00149
        • Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
      • Torino, Italy, 20126
        • Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
  • Poland
      • Bydgoszcz, Poland, 85-030
        • Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
      • Chorzow, Poland, 41-500
        • Szpital Specjalistyczny
      • Krakow, Poland, 31-531
        • Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego
      • Szczecin, Poland, 71-455
        • Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej
      • Warszawa, Poland, 00-909
        • Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM
      • Warszawa, Poland, 01-201
        • Wojewodzki Szpital Zakazny
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Fundacion de Investigacion de Diego
  • Russian Federation
      • Moscow, Russian Federation, 115516
        • Russian State Medical University
      • Smolensk, Russian Federation, 214018
        • Smolensk Medical Academy
      • St.Petersburg, Russian Federation, 190020
        • City Hospital of Infectious Diseases #10
      • St.Petersburg, Russian Federation, 193163
        • Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
      • St.Petersburg, Russian Federation, 193167
        • City Hospital of Infectious Diseases #30
      • St.Petersburg, Russian Federation, 194175
        • Department of infectious diseases, Russian Military Academy
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28029
        • Hospital Carlos III
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Liver Unit, Royal Infirmary of Edinburgh
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-5136
        • University of Arizona
    • California
      • Fresno, California, United States, 93702
        • UCSF Fresno- Internal Medicine
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine, University of Southern California
      • Newport Beach, California, United States, 92633
        • Orange Coast Medical Group
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • San Diego, California, United States, 92115
        • Research and Education, Inc.
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Mateo, California, United States, 94403
        • San Mateo Medical Center
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
      • Lakewood, Colorado, United States, 80215
        • Rocky Mountain Gastroenterology
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bach and Godofsky
      • Jacksonville, Florida, United States, 32216
        • Mayo Clinic Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States, 30033
        • Atlanta Academic Research Group
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70115
        • Louisiana State University Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University Medical Center
      • Laurel, Maryland, United States, 20707
        • Maryland Digestive Disease Research
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Future Care Studies/Northgate Medical
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Bradley Freilich, MD
      • St. Louis, Missouri, United States, 63104
        • Saint Louis University School of Medicine
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Atlantic Gastroenterology Associates
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Bronx, New York, United States, 10468
        • Bronx VA Medical Center
      • Johnson City, New York, United States, 13790
        • Regional Clinical Research, Inc.
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Cabrini Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Research Solutions (SMO)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Austin, Texas, United States, 78758
        • Radiant Research - Austin
      • Dallas, Texas, United States, 75390
        • University of Texas
      • Houston, Texas, United States, 77030
        • Va Medical Center
    • Virginia
      • Annadale, Virginia, United States, 22003
        • Inova Fairfax Hospital
      • Falls Church, Virginia, United States, 22046
        • Kaiser Permanente Medical Center
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- 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

Outcome Measure
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 30, 2004

First Submitted That Met QC Criteria

October 1, 2004

First Posted (Estimate)

October 4, 2004

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNA003142-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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