A Phase 2 Open-Label Multicenter Multi-cohort Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children with Genotype 2 or 3 Chronic HCV Infection
Investigating the Safety and Efficacy of an Investigational Medication for Children with Hepatitis C
Brief description of study.
The purpose of this study is to see if giving SOF with RBV for 12 or 24 weeks to children with GT2 or GT# HCV is safe and can treat their HCV.
Detailed description of study
The purpose of this study is to evaluate the efficacy and safety of treatment with SOF+RBV for adolescents and children with GT-2 and GT-3 chronic HCV infection.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: hepatitis
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Age: 3 years - 17 years
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Gender: All
The purpose of this study is to evaluate the safety and effectiveness of an investigational medication in treating children and adolescents with chronic Hepatitis C infection, specifically genotypes 2 and 3. Hepatitis C is a liver infection caused by the Hepatitis C virus (HCV), and genotypes refer to the genetic variations of the virus. The study aims to determine if the investigational medication, given with another treatment, can effectively manage the condition in this age group.
Participants in the study will receive the investigational medication along with a second treatment for either 12 or 24 weeks. The study will monitor the safety of the treatment and how well it works in reducing the Hepatitis C virus in the body. Children and adolescents with genotypes 2 and 3 of the virus will be included to assess the treatment's impact on their health.
- Who can participate: This study is for children and adolescents with chronic Hepatitis C infection, specifically those with genotypes 2 and 3 of the virus.
- Study details: Participants will receive an investigational medication along with another treatment. The study will monitor the effects of the treatment on the Hepatitis C virus. A placebo, which is an inactive substance, will not be used in this study.
Interested in the study?
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