CompletedPhase 3

The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

121 participantsStarted 2015-11

Plain-language summary

The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
✓. Chronic HCV infection.
✓. HCV treatment-naïve or treatment experienced (interferon \[IFN\] or pegylated interferon \[pegIFN\] with or without ribavirin \[RBV\]; sofosbuvir \[SOF\] plus RBV with or without pegIFN).
✓. Non-cirrhotic participants.

Exclusion criteria

✕. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
✕. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
✕. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
✕. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
✕. Co-infection with more than one HCV genotype.

What they're measuring

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Timeframe: 12 weeks after the last actual dose of study drug

Trial details

NCT IDNCT02636595

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10

Results submitted2017-08-17

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