Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir
ConditionHepatitis C
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKirby Institute
About this trial
This study aims to evaluate the efficacy, safety and feasibility of four weeks of sofosbuvir plus glecaprevir-pibrentasvir, followed by immediate retreatment of virological relapse with glecepravir-pibrentasvir for 12 weeks, in treatment-naïve participants with chronic HCV infection and early liver disease (F0-F2).
Eligibility criteria
Qualifiers
Have voluntarily signed the informed consent form.
18 years of age or older.
Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
Quantifiable HCV RNA at screening.
Disqualifiers
Participants who meet any of the exclusion criteria are not to be enrolled in this study.
Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
Solid organ transplant.
Trial design
Treatments tested in this trial
- Sofosbuvir 400mg [Sovaldi]
- Glecaprevir/pibrentasvir (300mg/120mg)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov