Phase 3
N=68
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Chronic Hepatitis C · Hepatitis C Virus · Compensated Cirrhosis · Severe Renal Impairment · End-stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT02207088 ↗Enrolled (actual)
68
Serious AEs
25.0%
Results posted
Nov 2017
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment — 94.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ombitasvir/paritaprevir/ritonavir (Drug); dasabuvir (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment |
94.1 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Post-Treatment Relapse |
1.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.
- Screening laboratory result indicating HCV genotype 1 infection.
- Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).
- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
- 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.
Data sourced from ClinicalTrials.gov (NCT02207088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.