Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin; Taribavirin

Criteria

Inclusion Criteria:

• Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients

• Body weight greater than 61 kg and not more than 87.3 kg

• HCV RNA greater than 2 million copies/mL

• Elevated measured or historical alanine aminotransferase

• Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males

• Calculated creatinine clearance greater than 70 mL/min

Exclusion Criteria:

• Cirrhosis of the liver

• Alanine aminotransferase greater than 3 times the upper limit of normal

• Severe neuropsychiatric disorders

• History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease

• Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)