Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.
Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
Time Frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Up to 24 weeks
Percentage of Participants With Post-Treatment Relapse
Time Frame: Within 12 weeks after the last dose of study drug
Interventions:
- Drug: ombitasvir/paritaprevir/ritonavir
- Drug: dasabuvir
- Drug: Ribavirin
Enrollment:
68
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
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