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

• ClinicalTrials.gov Identifier: NCT00093093
• Recruitment Status: Completed
• First Posted: October 4, 2004
• Last Update Posted: June 22, 2012
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Tracking Information

• First Submitted Date: September 30, 2004
• First Posted Date: October 4, 2004
• Last Update Posted Date: June 22, 2012
• Study Start Date: June 2004
• Actual Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2005)

• - 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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 28, 2005)

• - 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
• 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
• 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.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Chronic Hepatitis C

Intervention

• Drug: Viramidine
• Drug: Ribavirin
• Drug: pegylated interferon alfa-2a

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 900
• Original Enrollment: Same as current
• Actual Study Completion Date: May 2006
• Actual Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Canada, France, Israel, Italy, Poland, Puerto Rico, Russian Federation, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT00093093
• Other Study ID Numbers: RNA003142-302
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bausch Health Americas, Inc.
• Study Sponsor: Bausch Health Americas, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Ralph T. Doyle; Bausch Health Americas, Inc.

• PRS Account: Bausch Health Americas, Inc.
• Verification Date: June 2012