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

Retrospective Analysis of Glecaprevir/Pibrentasvir Safety and Concomitant Medications Through Integrated Real-World Data

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07419347

Enrollment

2000

Registered

2026-02-19

Start date

2026-02-27

Completion date

2026-06-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Experiencing Adverse Events	Up to approximately 210 days	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN)	Up to approximately 210 days	ALT and AST levels will be assessed.
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3x Upper Limit of Normal (ULN) With Total Bilirubin > 2x ULN	Up to approximately 210 days	ALT, AST and Bilirubin levels will be assessed.

Countries

Canada

Contacts

CONTACTDimitri Semizarov

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

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results