Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders
Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC)
treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1
chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).
Null-responders are defined as patients who failed to achieve a greater than 2 log drop in
HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels after 12 weeks of
treatment (know as an "early virologic response", or EVR) during previous SOC therapy.
If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week
12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that
patient is not a null-responder, and is excluded from study participation. If, during
previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must
have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined
as a null-responder.
Patients will be screened and have up to 4 weeks to qualify for study entry. During this
screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients
will undergo centralized, stratified (based on ethnicity), randomization to one of four
treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will
last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo
patients who do not show a virologic response after 12 weeks of therapy will be rolled onto
SOC + 15mg CTS-1027, while maintaining the study blind.