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

Korábbi kezelés

• Received solid organ or bone marrow transplant
• Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants
• Malignancy within the 5 years prior to screening. Individuals under evaluation for possible malignancy are not eligible.

Más betegség

• Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
• Any history of, or current evidence of, clinical hepatic decompensation
• Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
• Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator

Egyéb

• 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.
• 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)
• Abnormal hematological and biochemical parameters
• Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

• 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