Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/ Pibrentasvir (Mayret) in Chronic Hepatitis C Patients (SMART-C)
Data has shown that direct-acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively, provides key features for HCV treatment simplification.
Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.
One post-treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this time point (SVR12).
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection (DORA)
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) (Mavyret) in pediatric (children) participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults.
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The study is evaluating the safety and effectiveness of Viekira Pak to treat pediatric patients with chronic hepatitis C genotypes 1 and 4. Viekira Pak is already approved by the Food and Drug Administration to treat adults with hepatitis C. This is the first clinical trial of Viekira Pak to treat pediatric patients.
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects (ZIRCON)
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