Safety, Tolerability and Efficacy of XTL 2125 in HCV-Infected Patients Who Are Interferon-Alpha Non-Responders or Relapsers
Status:
Withdrawn
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
The study will be a randomized, double blind, placebo controlled, dose rising study in
Interferon alpha (IFN-alpha) non-responder HCV infected patients or HCV patients who have
relapsed following IFN-alpha therapy. Eligible subjects must have compensated liver disease
and serum HCV RNA concentrations above 100,000 IU/mL at screening. The study will include
both a single dose period for the evaluation of acute toxicity and single dose
pharmacokinetics and a consecutive multi-dose period for the determination of longer-term
safety, multiple-dose pharmacokinetics and antiviral activity. The objectives of this study
are to evaluate the safety, tolerability, and antiviral activity of escalating single and
multiple doses of XTL 2125 in patients with chronic hepatitis C virus infection and to assess
the single- and multiple-dose pharmacokinetics of XTL 2125