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
1 other identifier
observational
2,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedStudy Start
First participant enrolled
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 16, 2026
April 1, 2026
3 months
February 12, 2026
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Experiencing Adverse Events
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.
Up to approximately 210 days
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN)
ALT and AST levels will be assessed.
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
ALT, AST and Bilirubin levels will be assessed.
Up to approximately 210 days
Study Arms (1)
Glecaprevir/Pibrentasvir
Data from participants prescribed Glecaprevir/pibrentasvir will be collected.
Eligibility Criteria
Participants with HCV prescribed 8 weeks of Glecaprevir/Pibrentasvir irrespective of participation in this study.
You may qualify if:
- 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.
You may not qualify if:
- Treated with DAAs other than G/P.
- History of decompensated cirrhosis.
- Had Hepatitis-B virus (HBV) infection.
- Had hepatocellular carcinoma (HCC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (2)
Vancouver Infectious Diseases Centre /ID# 275313
Vancouver, British Columbia, V6Z 2C7, Canada
St. Clair Medical Clinic /ID# 275334
Toronto, Ontario, M4S 1Y2, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start
February 27, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04