Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in Treatment-Naïve HCV Genotype 1-Infected Adults With Chronic Kidney Disease


About this study

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week regimen of ombitasvir/ABT-450/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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.
  2. Screening laboratory result indicating HCV genotype 1 infection.
  3. 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).
  4. 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:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
  3. 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information


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Study Results Summary

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Supplemental Study Information

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