CompletedNot Applicable

The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

Japan344 participantsStarted 2016-01-14

Plain-language summary

This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement. * Participants who agree to sign the informed consent Exclusion Criteria: * Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.

What they're measuring

Hepatitis C virus ribonucleic acid (HCV RNA) levels

Timeframe: 60 months after completion of the 2D treatment in M12-536 or M13-004 study

Trial details

NCT IDNCT02581020

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-12-08

View on ClinicalTrials.gov More Hepatitis C Virus trials