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 |
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.
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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