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 |
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
We found this trial at
10
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials