Recruiting

Glecaprevir/Pibrentasvir

Sponsor:

AbbVie

Code:

NCT07419347

Conditions

Hepatitis C Virus (HCV)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Hepatitis C Virus (HCV)

Study ID

NCT07419347

Start date

Feb 27, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Glecaprevir/Pibrentasvir

Data from participants prescribed Glecaprevir/pibrentasvir will be collected.

Primary outcome measure

  • Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 210 days ]
  • Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN) [ Time Frame: 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 [ Time Frame: Up to approximately 210 days ]

Central Contacts and Locations

Central contacts

Dimitri Semizarov

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

Locations

Vancouver Infectious Diseases Centre /ID# 275313

Recruiting

Vancouver, British Columbia, Canada, V6Z 2C7

St. Clair Medical Clinic /ID# 275334

Recruiting

Toronto, Ontario, Canada, M4S 1Y2

More Information

Sponsor

AbbVie

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Hepatitis C Virus (HCV)
  • Glecaprevir
  • Pibrentasvir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-04-16.