We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00093093
Recruitment Status : Completed
First Posted : October 4, 2004
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Viramidine Drug: Ribavirin Drug: pegylated interferon alfa-2a Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Study Start Date : June 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
  2. - 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 :
  1. - Efficacy: Undetectable plasma HCV RNA at treatment week 24
  2. - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
  3. - Safety: Monitoring of adverse events
  4. - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093093


Locations
Show Show 100 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
Layout table for investigator information
Study Director: Ralph T. Doyle Bausch Health Americas, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00093093    
Other Study ID Numbers: RNA003142-302
First Posted: October 4, 2004    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by Bausch Health Americas, Inc.:
Viramidine
Ribavirin
Valeant
Hepatitis C
Pegylated interferon alfa-2a
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Taribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs