Phase 3
Completed N=18
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT02487199 ↗
Enrolled (actual)
18
Serious AEs
22.2%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 100; 80.0 percentage of participants
◆ Published Evidence
Emerging
7citations · ~1 / year
Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials.
Summary
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.
Linked Publications
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Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
100; 80.0 | — |
| PRIMARY Number of Participants With Adverse Events |
13; 5; 3; 1 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
- Chronic kidney disease stage 4 or stage 5.
Exclusion Criteria
- Females who are pregnant or breastfeeding
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
- Abnormal laboratory tests
- Current enrollment in another investigational study
- Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
- Current treatment with a direct acting antiviral agent (DAA) containing regimen
- Any evidence of liver cirrhosis or liver cancer
Data sourced from ClinicalTrials.gov (NCT02487199) and the linked publication. 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. Informational only — not medical advice.