A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450… (NCT01685203) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
316 participantsStarted 2012-08
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
* Subjects must meet one of the following:
* Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
* Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
* Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2.
* Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
* Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening
Exclusion Criteria:
* History of severe, life-threatening or other significant sensitivity to any drug.
* Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
* Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
* Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.
What they're measuring
1
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
Timeframe: 12 weeks after the last actual dose of study drug