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

Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00230958

Enrollment

900

Registered

2005-10-03

Start date

2003-12-31

Completion date

2006-01-31

Last updated

2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

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

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.

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)

Interventions

DRUGViramidine

DRUGRibavirin

DRUGpegylated interferon alfa-2b

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- 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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026