Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype-1 Patients With Chronic HCV Infection
Status: | Archived |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | December 2010 |
End Date: | May 2013 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection
Assess the safety and efficacy of ANA598 administered with Pegylated Interferon and
Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection.
Eligible patients with chronic hepatitis C infection (HCV genotype 1) will be randomized to
treatment with 200 mg BID (total daily dose 400 mg) ANA598 or matching placebo, while
receiving co-administered pegylated interferon and ribavirin (standard-of-care, SOC). All
patients receiving ANA598 will receive a loading dose of 800 mg BID (total dose 1600 mg) on
Day 1.
Treatment-Naïve Patients:
Enrollment will include approximately 133 treatment-naïve Genotype 1 patients with chronic
HCV infection (100 randomized to receive ANA598 + SOC, and 33 randomized to receive matching
placebo + SOC).
Treatment-naïve patients will be treated for either 28 weeks or 48 weeks, depending on
response to treatment. Patients with undetectable HCV RNA at Week 8 and at subsequent
visits will complete all treatment at Week 28.
Patients with Prior SOC Treatment (All will receive 48 Weeks of therapy):
Approximately 113 patients categorized as having prior relapse , prior partial response or
prior viral breakthrough to previous treatment will be randomized to treatment with ANA598
200 mg BID + SOC or placebo + SOC (80 randomized to be treated with ANA598 + SOC, and 33
randomized to be treated with placebo + SOC).
Approximately 28 treatment-experienced patients categorized as null responders to previous
treatment will be assigned treatment for 48 weeks with ANA598 200mg BID and co-administered
pegylated interferon and ribavirin.
We found this trial at
13
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