A Study to Evaluate the Safety and Effect of ABT-450, Ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis



Status:Completed
Conditions:Infectious Disease, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:3/30/2013
Start Date:October 2012
End Date:September 2014
Contact:Melanie Gloria, BS
Email:melanie.gloria@abbvie.com
Phone:847-936-0714

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A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)


The purpose of this study is to evaluate the safety and effect of ABT-450, ritonavir and
ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with ribavirin (RBV) in HCV genotype
1-infected adults with compensated cirrhosis.


Inclusion Criteria:

- Male or female and age is between 18 and 70 years, inclusive, at time of Screening.

- Chronic HCV-infection prior to study enrollment.

- Screening laboratory result indicating HCV genotype 1-infection.

- Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at
Screening

- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
Immunodeficiency virus antibody (HIV Ab) at screening.

- Prior therapy with direct acting antiviral agents for the treatment of HCV, including
telaprevir and boceprevir.

- Any current or past clinical evidence of Child-Pugh B or C Classification or clinical
history of liver decompensation including ascites (noted on physical exam), variceal
bleeding or hepatic encephalopathy.

- A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a
subsequent CT Scan or MRI during the screening period.

- Any cause of liver disease other than chronic HCV-infection, including but not
limited to the following:

- Hemochromatosis

- Alpha-1 antitrypsin deficiency

- Wilson's disease

- Autoimmune hepatitis

- Alcoholic liver disease

- Nonalcoholic steatohepatitis

- Drug-related liver disease
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