This study is currently not recruiting participants.

A Phase 2 Open-Label Multicenter Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children with Chronic HCV-Infection

Investigating the Safety and Impact of an Investigational Medication in Children with Chronic HCV

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

This is an open-label, multi-cohort, two-part study evaluating the PK, safety, and antiviral activity of LDV/SOF FDC in chronic HCV-infected pediatric subjects.

Detailed description of study

This is an open-label, multi-cohort, two-part study evaluating the PK, safety, and antiviral activity of LDV/SOF FDC in chronic HCV-infected pediatric subjects.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: hepatitis
  • Age: 100 years or below
  • Gender: All

This study investigates the safety and effects of an investigational medication in children with chronic hepatitis C virus (HCV) infection. Hepatitis C is a liver disease caused by the hepatitis C virus. This study aims to understand how the medication is processed in the body (pharmacokinetics) and its antiviral activity, which means how well it works against the virus.

Participants in the study will receive the investigational medication, and researchers will monitor them to see how their bodies respond. This involves checking for any side effects and measuring the levels of the virus in their blood. An open-label study means that both the researchers and participants know what medication is being given.

  • Who can participate: Children with chronic HCV infection are eligible to participate in this study. Participants must meet specific health criteria and be within a certain age range as determined by the study requirements.
  • Study details: Participants will take the investigational medication and undergo regular health checks. The study will monitor their response to the medication and any side effects.
Updated on 19 Feb 2024. Study ID: 1408911834

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the study team