A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection



Status:Active, not recruiting
Conditions:Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:November 2005
End Date:November 2016

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An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)

This is a study to evaluate the safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and
Dasabuvir with or without Ribavirin in US veterans with genotype 1 chronic hepatitis C virus
infection.


Inclusion Criteria:

1. US military veteran currently receiving healthcare through the Veterans Health
Administration

2. Screening laboratory result indicating HCV, genotype 1-infection

3. Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening,
and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the
time of Screening with a liver biopsy consistent with chronic HCV-infection (or a
liver biopsy performed prior to enrollment with evidence of chronic hepatitis C
disease)

Exclusion Criteria:

1. Women who are pregnant or breastfeeding

2. Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies
(HIV Ab)

3. Prior or current use of any investigational or commercially available anti-HCV agents
other than IFN, pegIFN, RBV or sofosbuvir

4. Any current or past clinical evidence of Child-Pugh B or C classification

5. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within
3 months prior to Screening or on an ultrasound performed at Screening for
participants with cirrhosis
We found this trial at
11
sites
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Boston, MA
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Bronx, NY
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Durham, NC
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Iowa City, IA
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Long Beach, CA
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Miami, FL
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Palo Alto, CA
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Richmond, VA
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San Francisco, CA
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San Juan,
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from
West Haven, CT
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