The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.
After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Moscow State University of Medicine and Dentistry
Moscow, Russia
Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.
Time frame: 12 weeks
Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.
Time frame: 4 weeks
Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.
Time frame: 24 weeks after last dose of study treatment
Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.
Time frame: After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.
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