Hepatitis C Clinical Trial
Official title:
An Open-Label Trial of Pegylated Interferon Plus Ribavirin in Combination With CTS-1027 in HCV Null-Responders
The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated interferon and ribavirin can improve the response rates in HCV patients who did not previously respond to pegylated interferon and ribavirin therapy.
A subset of non-responders to standard of care treatments (pegylated interferon and
ribavrin) is termed null responders. Null responders are the most treatment refractory
population. Treatment for null responders is currently limited: retreatment with SOC results
in approximately 5% sustained virologic response (SVR).
CTS-1027 may facilitate the activity of interferon by preventing MMP-induced cleavage and
deactivation in both phases of clinical response to therapy. In addition, CTS-1027, like
ribavirin, alone does not significantly affect viral replication, but both CTS-1027 and
ribavirin are likely to impact response to therapy during the second and slower phase of the
clinical response.
The potential of MMP inhibition to facilitate the action of interferon, together with
ribavirin-driven up-regulation of interferon stimulated genes, has the potential to yield a
potent host immune response in this highly resistant null-responder patient population.
Again, since MMP inhibition is thought to target the second slower phase kinetics, the
initial treatment duration in this trial will be 24 weeks.
This trial will evaluate the safety and efficacy of CTS-1027 combined with SOC in patients
who did not previously respond to SOC therapy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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