Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Infection
Compensated Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosi...
Detailed Description
This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and pr...
Eligibility Criteria
Inclusion
- 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).
- Screening laboratory result indicating HCV genotype 1b-infection.
- Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.
Exclusion
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
- 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.
- 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.)
- Use of contraindicated medications within 2 weeks of dosing
- 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. Participants 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02219503
Start Date
September 1 2014
End Date
September 1 2015
Last Update
July 12 2021
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