Chronic Hepatitis C Clinical Trial
Official title:
Efficacy and Safety of a Hansenula-derived Pegylated Interferon α2a (Reiferon Retard®) in Treatment of Patients With Chronic Hepatitis C Virus Infection: A National Multi-center Phase IV Open Label Non-Randomized Trial
It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant
interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in
treatment of Egyptian patients with chronic hepatitis C for 48 weeks.
hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end
of treatment, as well as 24 weeks after therapy is completed.
Multicenter , Phase IV, open labeled, non-randomized trial to assess the Efficacy of
Hansenula-derived recombinant pegylated interferon α 2a (Reiferon Retard® in treatment of
naïve chronic hepatitis c virus Egyptian patients.
Each participant will be subject to thorough history taking, complete clinical examination,
Biochemical laboratory and hematological tests, U/S imaging as well as histologic assessment
of liver disease stage and severity to ensure his/her eligibility to be enrolled in the
study according to predetermined inclusion and exclusion criteria .
Eligible subjects will be treated with Reiferon Retard® 160 µg once weekly by subcutaneous
injection for 48 weeks treatment plus weight-based Ribavirin orally (1200 mg/kg daily for
those > 75 Kg or 1000mg/Kg daily for those ≤ 75 kg in divided doses). HCV RNA will be
assessed at week 12 of initiation of therapy to identify Early Virologic Response (EVR), at
week 24 to identify breakthrough viremia, at week 48 to identify End of treatment Response
(ETR), and at week 72 to identify Sustained Virologic Response (SVR).
All subjects will be followed up during the study as described in the table below (Section 4
Study Design).
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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