Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 willing to sign a consent form/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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

TAF

Administered orally once daily

DRUG

Placebo

Administered orally once daily

Locations (20)

Children's Hospital of Los Angeles
Los Angeles, California, United States
Rady Childrens Hospital
San Diego, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, United States
AdventHealth Medical Group
Orlando, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital - Main Hospital
Houston, Texas, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States