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Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive

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: NCT00230958
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.

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

Detailed Description:
Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2003
Primary Completion Date : January 2006
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, opthalmologic disorders including severe retinopathy, or immune mediated disease
  • Pregnant or breast-feeding patients
Contacts and Locations

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): NCT00230958


Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Ralph T. Doyle Valeant Pharmaceuticals International, Inc.
More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00230958     History of Changes
Other Study ID Numbers: RNA003142-301
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Viramidine
Ribavirin
Valeant
Hepatitis C
Pegylated interferon alfa-2b

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs