Chronic Hepatitis C
Conditions
Keywords
Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2a
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)
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, ophthalmologic 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 | — |
Countries
Argentina, Australia, Canada, France, Israel, Italy, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Outcome results
None listed