Tenofovir Alafenamide (TAF) in Children and Adolescents With Chronic Hepatitis B Virus Infection

• Status: Recruiting
• Trial end date: 2029-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

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 = ≥ 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/1.73m^2 (using the Schwartz formula)

• Normal ECG

Key Exclusion criteria:

• 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.