Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Philip Rosenthal

Description

Summary

The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB). Cohort 2 will consist of 2 parts: Part A and Part B. Intensive pharmacokinetic (PK) data will be collected from all participants in Part A to confirm the dose of TAF in each dose group and the remaining participants will be enrolled into Part B once dose confirmation is achieved. The primary objectives of Part A are to evaluate the steady-state PK of TAF and tenofovir (TFV) and confirm the dose of TAF given once daily in children (aged 2 to < 12 years) with CHB. The primary objective of Part B is to evaluate the safety and tolerability of TAF at Week 48 and the antiviral activity (HBV DNA < 20 IU/mL) of TAF at Week 24 in children (aged 2 to < 12 years) with CHB.

Official Title

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

Keywords

Chronic Hepatitis B CHB HBV Hepatitis A Hepatitis B Hepatitis B, Chronic Virus Diseases Herpesviridae Infections Hepatitis Hepatitis, Chronic TAF Open-Label TAF

Eligibility

You can join if…

Open to people ages 2-17

  • 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 = ≥ 17 kg to < 25 kg (≥ 37 lbs to <55 lbs)
  • Cohort 2 Group 3 = < 17 kg (< 37 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)
  • Treatment-naive or treatment-experienced will be eligible for enrollment.
  • Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m2 (using the Schwartz formula)

  • Normal ECG

You CAN'T join if...

  • Females who are 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.

Locations

  • University of California, San Francisco (UCSF) accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02932150
Phase
Phase 2
Study Type
Interventional
Last Updated