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

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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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San Antonio, Texas 78215
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2160 South First Avenue
Proviso, Illinois 60153
(708) 216-0291
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Arlington, Texas 76012
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Bakersfield, California 93301
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Bradenton, Florida 34209
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Cincinnati, Ohio 45267
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Detroit, Michigan 48202
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Englewood, Colorado 80113
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Houston, Texas 77030
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Kansas City, Missouri 64131
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Marietta, Georgia 30060
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Nashville, Tennessee 37205
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Nashville, Tennessee 37211
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