Study of Glecaprevir/Pibrentasvir to Assess Safety Through Real-World Data
ConditionHepatitis C Virus (HCV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Treated with DAAs other than G/P.
History of decompensated cirrhosis.
Had Hepatitis-B virus (HBV) infection.
Had hepatocellular carcinoma (HCC).
Trial population
Participants with HCV prescribed 8 weeks of Glecaprevir/Pibrentasvir irrespective of participation in this study.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: Glecaprevir/Pibrentasvir
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to approximately 210 days2
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.
Time frame
Up to approximately 210 days3
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.
Time frame
Up to approximately 210 days Source ClinicalTrials.gov