This study is currently not recruiting participants.

A Randomized Double-Blind Evaluation of the Pharmacokinetics Safety and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Adolescents with Chronic Hepatitis B Virus Infection

Evaluating the Safety and Effectiveness of an Investigational Medication for Hepatitis B in Adolescents

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of TAF against the Hepatitis B Virus in all of the enrolled adolescent subjects.

Detailed description of study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of TAF against the Hepatitis B Virus in all of the enrolled adolescent subjects.

Eligibility of study

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

  • Conditions: Chronic Hepatitis B Virus Infection
  • Age: 100 years or below
  • Gender: All

This study investigates the safety, tolerability, and effectiveness of an investigational medication in adolescents with Hepatitis B. Hepatitis B is a liver infection caused by the Hepatitis B virus, which can lead to serious liver damage if not treated.

Participants in this study will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor the participants for any side effects and measure how well the investigational medication works against the virus.

  • Who can participate: Adolescents aged 12 to 17 years with a diagnosis of chronic Hepatitis B are eligible to participate. Key inclusion criteria include stable liver function tests and no history of liver transplantation.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The study will monitor the effects of the treatment on Hepatitis B virus levels and any side effects.
Updated on 19 Feb 2024. Study ID: 1611090671

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