Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Virus Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Ch...
Eligibility Criteria
Inclusion
- Chronic HCV infection prior to study enrollment.
- Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
- Absence OR presence of cirrhosis.
- If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)
Exclusion
- Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
- Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
- Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
- Abnormal lab tests.
- Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant
Key Trial Info
Start Date :
December 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02292719
Start Date
December 19 2014
End Date
July 14 2017
Last Update
July 12 2021
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