Hepatitis C Virus (HCV)NCT07419347
Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus (HCV)
- How many people
- 2,000 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Feb 2026to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with HCV prescribed 8 weeks of Glecaprevir/Pibrentasvir irrespective of participation in this study.
Who may be able to join
- 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.
Who cannot join
- Treated with DAAs other than G/P.
- History of decompensated cirrhosis.
- Had Hepatitis-B virus (HBV) infection.
- Had hepatocellular carcinoma (HCC).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
St. Clair Medical Clinic /ID# 275334
Toronto, Ontario, M4S 1Y2
- Recruiting
Vancouver Infectious Diseases Centre /ID# 275313
Vancouver, British Columbia, V6Z 2C7
About this study
Official title: Retrospective Analysis of Glecaprevir/Pibrentasvir Safety and Concomitant Medications Through Integrated 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.
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glecaprevir/Pibrentasvir | Data from participants prescribed Glecaprevir/pibrentasvir will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 210 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start27 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419347
- Sponsor's protocol ID
- P25-554
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Glecaprevir/Pibrentasvir Safety and Concomitant Medications Through Integrated Real-World Data
- ClinicalTrials.gov ID
- NCT07419347
- Acronym / sponsor ID
- P25-554
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glecaprevir/Pibrentasvir | – | –Data from participants prescribed Glecaprevir/pibrentasvir will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with HCV prescribed 8 weeks of Glecaprevir/Pibrentasvir irrespective of participation in this study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Treated with DAAs other than G/P.
- History of decompensated cirrhosis.
- Had Hepatitis-B virus (HBV) infection.
- Had hepatocellular carcinoma (HCC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitri Semizarov (+1 847-935-8741, dimitri.semizarov@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Adverse Events (time frame: Up to approximately 210 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.