Hepatitis C Clinical Trial
Official title:
A Randomized, Active-Control Phase II Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic Hepatitis C Virus Genotype 1 Infection
This will be a randomized, open-label, active-control Phase II pilot trial of bavituximab
combined with ribavirin for initial treatment of chronic HCV genotype 1 infection. Eligible
patients with normal coagulation, hematological, and renal function will undergo a
screening/washout period of up to 28 days, followed by randomization to receive weekly
bavituximab or PEG-IFN alpha-2a therapy for 12 weeks, both with twice-daily ribavirin.
The primary endpoint of this study is the proportion of patients who show a greater than or
equal to 2-log10 IU reduction in plasma HCV RNA level after 12 weeks of treatment (early
virological response; EVR).
Secondary endpoints include the proportion of patients with an undetectable HCV RNA level
after 12 weeks of treatment; the proportion of patients who show a reduction in HCV RNA
level of greater than or equal to 2 log10 IU after 4 weeks of treatment, viral kinetics for
individual patients over time, and comprehensive evaluation of the safety and tolerability
of bavituximab infusion.
Primary Objective: The primary objective of this study is to assess the effect of 12 weeks of initial treatment with bavituximab versus PEG-IFN, each combined with ribavirin, on plasma HCV RNA level in patients with chronic HCV genotype 1 infection. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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