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

This study has been completed.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc. Identifier:
First received: September 29, 2005
Last updated: June 21, 2012
Last verified: June 2012
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 Intervention Phase
Chronic Hepatitis C
Drug: Viramidine
Drug: Ribavirin
Drug: pegylated interferon alfa-2b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • - 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:
  • - 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

Estimated Enrollment: 900
Study Start Date: December 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00230958

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

Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT00230958     History of Changes
Other Study ID Numbers: RNA003142-301 
Study First Received: September 29, 2005
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2b
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016