Tatarstan

Researchers are evaluating the safety, tolerability, and effectiveness of the drug tenofovir alafenamide (TAF) compared to a placebo in children and teenagers who have chronic hepatitis B virus (CHB) infection. The study aims to understand the appropriate dosing levels for children and teens and is conducted as a Phase 2 clinical trial. Participants include males and females who meet specific health and laboratory criteria related to their hepatitis B infection. Participants are randomly assigned to receive either TAF or a placebo, both administered orally once daily. The study involves different cohorts based on weight to assess dosing accurately. The treatment and monitoring phases last up to 24 weeks, during which the drug's effects and safety are closely observed. The study also collects pharmacokinetic data to understand how the drug behaves in the body over time. During the study, participants will undergo regular evaluations including blood tests to measure hepatitis B viral levels and liver enzymes, electrocardiograms (ECGs) to monitor heart function, and safety assessments for any adverse events. Researchers will track how many participants experience serious or any adverse events by week 24, as well as the percentage of participants achieving low levels of hepatitis B virus in their blood. The study requires informed consent and ongoing cooperation from participants and their guardians throughout the trial duration.