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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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