Status:
COMPLETED
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype...
Detailed Description
This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatm...
Eligibility Criteria
Inclusion
- Participants who had a body mass index 18 to \< 35 kg/m\^2.
- Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
- Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
- Participants were in a condition of general good health, other than the HCV infection.
- Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA \> 50,000 IU/mL, and FibroTest score \<= 0.72 and aspartate aminotransferase (AST) to platelet ratio index \<= 2, Fibroscan® result of \< 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.
Exclusion
- Positive drug screen
- Previous use of anti-HCV agents
- History of cardiac disease
- History of uncontrolled diabetes or diabetes requiring insulin
- Abnormal laboratory results
- Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01458535
Start Date
September 1 2011
End Date
May 1 2013
Last Update
July 11 2016
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