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

NCT00230958 | Completed Phase 3

• 1 other identifier: RNA003142-301
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C

Keywords

Viramidine; Ribavirin; Valeant; Hepatitis C; Pegylated interferon alfa-2b

Outcome Measures

Primary Outcomes (2)

• - 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 Outcomes (4)

• - 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

Interventions

Viramidine DRUG

Ribavirin DRUG

pegylated interferon alfa-2b DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

taribavirin; Ribavirin; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ralph T. Doyle

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: October 3, 2005
• Study Start: December 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: June 22, 2012

Record last verified: 2012-06