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

Use our guide to learn which trials are right for you!

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
sites
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
Click here to add this to my saved trials
2160 South First Avenue
Proviso, Illinois 60153
(708) 216-0291
1724
mi
from 98109
Proviso, IL
Click here to add this to my saved trials
Arlington, Texas 76012
1668
mi
from 98109
Arlington, TX
Click here to add this to my saved trials
Bakersfield, California 93301
863
mi
from 98109
Bakersfield, CA
Click here to add this to my saved trials
Bradenton, Florida 34209
2541
mi
from 98109
Bradenton, FL
Click here to add this to my saved trials
Cincinnati, Ohio 45267
1963
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
Detroit, Michigan 48202
1930
mi
from 98109
Detroit, MI
Click here to add this to my saved trials
Englewood, Colorado 80113
1024
mi
from 98109
Englewood, CO
Click here to add this to my saved trials
Kansas City, Missouri 64131
1508
mi
from 98109
Kansas City, MO
Click here to add this to my saved trials
Marietta, Georgia 30060
2164
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
Nashville, Tennessee 37205
1969
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37211
1977
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
San Antonio, Texas 78215
1786
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials