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

Study on Investigational Medication for Chronic Hepatitis B in Adolescents

J
Jean Molleston, MD

Primary Investigator

Enrolling By Invitation
2 years - 18 years
All
Phase N/A
1 Location

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 children and adolescents. The 25 mg dose of TAF is the dose that has been selected for studies in adults with chronic hepatitis B. In a type of testing called pharmacokinetics (PK), researchers will measure the amount of TAF in the child’s blood and determine how the body takes in, distributes, processes, and removes it.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants will be identified utilizing an IRB approved database of current patients who are actively being seen by our department's physicians, medical records or clinic schedules, or physician/provider referral. We will contact those who are established standard of care patients and have been added to the hepatitis IRB approved database.

Detailed description of study

Approximately 68 subjects will continue to receive TAF or placebo and return for scheduled study visits through Week 24. After week 24, the study becomes open label and all subjects in Cohort 1 (age 12-18 years) will continue to receive 25mg of Tenofavir study drug once daily. 
 
Cohort 2 will enroll approximately 75 children in to 3 Groups depending on age and weight. Subjects will receive TAF or placebo through week 24. 
 
Subjects in part A will include PK testing. 
 
After week 24, the subjects in Cohort 2 will continue to receive open label TAF. 
 
The duration of the study is 50 months, including 24 weeks of treatment with the study drug and then an additional 216 weeks. The subjects will visit the clinic 6 times after the screening visit for the treatment portion and then at least 12 times for the follow up open-label portion of 216 weeks.

Eligibility of study

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

  • Conditions: Chronic Hepatitis B Virus Infection, Riley
  • Age: 2 years - 18 years
  • Gender: All

Key Inclusion criteria:

  • Males and non-pregnant, non-lactating females
  • Weight at screening as follows:
    • Cohort 1 = ≥ 35 kg (≥ 77 lbs)
    • Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs)
    • Cohort 2 Group 2 = ≥ 14 kg to < 25 kg (≥ 30 lbs to <55 lbs)
    • Cohort 2 Group 3 = ≥ 10 kg to < 14 kg (≥ 22 lbs to < 30 lbs) or
      • 14 kg to < 25 kg (≥ 30 lbs to < 55 lbs)
  • Willing and able to provide written informed consent/assent (child and parent/legal guardian)
  • Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
  • HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:
    • Screening HBV DNA ≥ 2 × 10^4 IU/mL
    • Screening serum ALT > 45 U/L (> 1.5 × ULN: 30 U/L) and ≤ 10 × ULN (by central laboratory range)
  • Treatment-naive or treatment-experienced will be eligible for enrollment.
  • Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m^2 (using the Schwartz formula)
  • Normal ECG

Key Exclusion criteria:

  • Females who are pregnant or breastfeeding
  • Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study.
  • Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
  • Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
  • Any history of, or current evidence of, clinical hepatic decompensation
  • Abnormal hematological and biochemical parameters
  • Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
  • Received solid organ or bone marrow transplant
  • Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants
  • Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
  • Malignancy within the 5 years prior to screening. Individuals under evaluation for possible malignancy are not eligible.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

This study investigates the effects of an investigational medication on adolescents with chronic hepatitis B virus infection. Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. The purpose of this study is to evaluate how safe the investigational medication is, how well it works, and how it behaves in the body. Researchers will measure the amount of the investigational medication in the blood to understand how the body absorbs, distributes, processes, and eliminates it.

Participants will be divided into two groups, called study arms. In the first 24 weeks, some participants will receive the investigational medication while others receive a placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine. After 24 weeks, all participants will receive the investigational medication. The study will include blood tests to monitor the investigational medication levels and check the health of the participants.

  • Who can participate: Children and adolescents aged 10 to 18 years with chronic hepatitis B can participate if they weigh at least 22 pounds and have specific blood test results. Participants should not have other liver diseases or infections like hepatitis C or HIV.
  • Study details: Participants will take the investigational medication or a placebo for 24 weeks, followed by the investigational medication for the rest of the study. They will have regular blood tests to monitor their health and the medication levels.
  • Study timelines and visits: The study will last 50 months. The study requires 18 visits.
Updated on 16 Dec 2025. Study ID: PGI-GILEAD-SUBBARAO-TAF, 1611090671
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only