RecruitingNot Applicable

Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data

Canada2,000 participantsStarted 2026-02-27

Plain-language summary

The objective of this study is to assess the safety, tolerability and effectiveness of 8-week Glecaprevir/Pibrentasvir (G/P) in participants taking either prescribed or illicit drugs.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * Prescribed 8 weeks of Glecaprevir/Pibrentasvir (G/P). * Treatment-naïve (for the current infection, participants that may have had prior infections which were resolved with treatment are considered naive for current infection as long as they have not received any treatment for the current infection.) * Is concomitantly on one or more prescription medications or illicit drugs. Exclusion Criteria: * Treated with DAAs other than G/P. * History of decompensated cirrhosis. * Had Hepatitis-B virus (HBV) infection. * Had hepatocellular carcinoma (HCC).

What they're measuring

Percentage of Participants Experiencing Adverse Events

Timeframe: Up to approximately 210 days

Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN)

Timeframe: Up to approximately 210 days

Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3x Upper Limit of Normal (ULN) With Total Bilirubin > 2x ULN

Timeframe: Up to approximately 210 days

Trial details

NCT IDNCT07419347

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Dimitri Semizarov

+1 847-935-8741 dimitri.semizarov@abbvie.com

View on ClinicalTrials.gov More Hepatitis C Virus (HCV) trials