Chronic Hepatitis C Virus Infection Clinical Trial
Official title:
HRN 003PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
HRN-003 STUDY SYNOPSIS
OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin
among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.
OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial
using PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth
twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly +
ribavirin by mouth twice daily for 48 weeks.
STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have
previously failed to achieve a sustained virologic response following interferon alfa or
interferon alfa-2b plus ribavirin therapy.
DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron
weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by
mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100
mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice
daily for 48 weeks.
EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study
medication doses will be obtained.
SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and
severity of adverse experiences and progression of disease, as measured by HCV viral load.
STUDY DESIGN
This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability
polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of
chronic hepatitis C virus infection in patients who have previously failed to achieve a
sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin
therapy. Patients will be stratified according to their response to the previous course of
therapy (i.e. non-reponse or relapse virologic pattern
This is a multi-center, randomized, open-label clinical trial that will involve
approximately 25 sites with an anticipated enrollment of 600 patients over a six-month
period.
Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5
mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks
OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by
subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.
- Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly +
ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).
- Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80
KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an
additional 48 weeks (Total therapy x 48 weeks).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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