A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:September 2014
End Date:September 2015

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An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in
Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis.


Inclusion Criteria:

1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is
defined as the following:

- Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months
before Screening, and positive for HCV RNA and anti-HCV Ab 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).

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

3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human
immunodeficiency virus (HIV) antibody (confirmed by Western Blot).

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

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. Screening laboratory analyses showing any of the following abnormal laboratory
results:

- Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min

- Albumin < 2.8 g/dL

- International normalized ratio (INR) > 1.8. Subjects with a known inherited
blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study
Designated Physician.

- Hemoglobin < 10 g/dL

- Platelets < 25,000 cells per mm3

- Total bilirubin > 3.0 mg/dL
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