Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic HepC Virus Genotype 1 Infection
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
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.