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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This study will recruit patients who have been diagnosed with acute (within 26 weeks) infection that are also infected with HIV (HIV/HCV coinfection). The goal of this trial is to find out if the treatment duration can be reduced from 12 weeks to 8 weeks in people who are infected with HCV genotype 1 and 4. A total of 80 patients will be enrolled. The drugs being used in this study are Zepatier (grazoprevir plus elbasvir) combined into one pill taken once-a-day.
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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