A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
Status: | Active, not recruiting |
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Conditions: | Infectious Disease, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/21/2016 |
Start Date: | November 2014 |
End Date: | February 2017 |
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and
Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir
with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and
Decompensated Cirrhosis.
Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir
with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and
Decompensated Cirrhosis.
Inclusion Criteria:
1. HCV Genotype 1(GT1)- or Genotype 4 (GT4)-infection defined as: Positive for anti-HCV
Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 infection at
Screening.
2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., CT or
MRI).
3. Child-Pugh Score 7 - 9 inclusive at time of Screening.
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 other investigational or commercially available anti-HCV
agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including
but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such
as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months
prior to Screening or on an ultrasound performed at Screening (a positive ultrasound
result will be confirmed with CT scan or MRI).
5. Any current or past evidence of Child-Pugh C classification.
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