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NCT Number: NCT07419347

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

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.

Recruiting

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Key information

Conditions

Hepatitis C Virus (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver Infectious Diseases Centre /ID# 275313, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Experiencing Adverse Events

    Time frame: 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.

  2. 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

    ALT and AST levels will be assessed.

  3. 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

    ALT, AST and Bilirubin levels will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitri Semizarov

CONTACT

[email protected]

+1 847-935-8741

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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