A Two-Part Open-Label Single-Arm Phase 1/2 Study of Safety Pharmacokinetics and Efficacy of Telaprevir in Combination With Peginterferon alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus
Investigating the Safety and Effectiveness of an Investigational Medication Combination for Chronic Hepatitis C in Children
Brief description of study.
The study is being done to learn more about the safety and the effectiveness of using Telaprevir in combination with two other medications to treat chronic hepatitis C in children.
Detailed description of study
The study is being done to learn more about the safety and the effectiveness of using Telaprevir in combination with two other medications to treat chronic hepatitis C in children.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hepatitis C
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Age: 3 years - 17 years
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Gender: All
This study investigates the safety and effectiveness of an investigational medication combination for treating chronic hepatitis C in children. Chronic hepatitis C is a long-lasting infection of the liver caused by the hepatitis C virus. This study aims to understand how well the investigational medication works when used with two other medications.
Participants in the study will receive the investigational medication along with two other medications. The study will monitor participants to understand the effects and any side effects of the treatment. The investigational medication is being tested for its ability to help manage chronic hepatitis C.
- Who can participate: Eligible participants are children aged 3 to 17 years with a confirmed diagnosis of chronic hepatitis C. Additional criteria include stable liver function tests and no prior treatment with direct-acting antivirals.
- Study details: Participants will take part in the study by receiving the investigational medication along with two other medications. They will be monitored for any effects and side effects. A placebo is not used in this study.
Interested in the study?
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