The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.
There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment. This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment. Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
Time frame: Baseline and 24 weeks
Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented. Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)
Time frame: Baseline and 24 weeks
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