Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

Description

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

Conditions

Chronic Hepatitis B

Talk to us

Study Overview

On this page

Study Details

Study overview

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescent Subjects With Chronic Hepatitis B Virus Infection

Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

Condition
Chronic Hepatitis B
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027

San Diego

Rady Childrens Hospital, San Diego, California, United States, 92123

San Francisco

University of California, San Francisco (UCSF), San Francisco, California, United States, 94158

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Miami

University of Miami/Schiff Center for Liver Diseases, Miami, Florida, United States, 33136

Orlando

AdventHealth Medical Group, Orlando, Florida, United States, 32803

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30322

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Minneapolis

University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2029-10