CTS-1027 in Interferon-Naive Hepatitis C Patients
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.
Drug: Placebo for ribavirin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients|
- Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
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)
- Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
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)
|Study Start Date:||June 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: CTS-1027 + ribavirin
Study drug plus ribavirin
200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks
Other Name: CopegusDrug: CTS-1027
5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks
Experimental: CTS-1027 + placebo
Study drug plus placebo for ribavirin
5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeksDrug: Placebo for ribavirin
Capsules identical to ribavirin in appearance containing inactive ingredients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925990
Show 21 Study Locations
|Study Chair:||Erin Castelloe, MD||Conatus Pharmaceuticals|