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NCT Number: NCT02932150

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires Saint-LUC UCL, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAF

Drug

Administered orally once daily

Placebo

Drug

Administered orally once daily

Primary outcomes

  1. Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24

    Time frame: Week 24

  2. Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24

    Time frame: Week 24

  3. Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24

    Time frame: Week 24

  4. PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Secondary outcomes

  1. Percentage of participants experiencing graded laboratory abnormalities

    Time frame: Weeks 24, 48, 96, and 240

  2. Development as measured by Tanner Stage Assessment

    Time frame: Weeks 24, 48, 96, and 240

  3. Percentage change from baseline in bone mineral density (BMD) of whole body (minus head) by dual imaging x-ray absorptiometry (DXA)

    Time frame: Baseline; Weeks 24, 48, 96, and 240

  4. Percentage change from baseline in BMD of lumbar spine by DXA

    Time frame: Baseline; Weeks 24, 48, 96, and 240

  5. Change from baseline in serum creatinine

    Time frame: Baseline; Weeks 4, 8, 12, 24, 48, 96, and 240

  6. Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula

    Time frame: Baseline; Weeks 24, 48, 96, and 240

  7. Incidence of treatment-emergent SAEs in participants treated with TAF or placebo for 24 weeks followed by open-label TAF at Weeks 48, 96 and 240

    Time frame: Weeks 48, 96, and 240

  8. Incidence of treatment-emergentAEs in participants treated with TAF or placebo for 24 weeks followed by open-label TAF at Weeks 48, 96 and 240

    Time frame: Weeks 48, 96, and 240

  9. Change from baseline in retinol-binding protein to creatine ratio at Weeks 4, 8, 12, 24, and 48

    Time frame: Baseline; Weeks 4, 8, 12, 24, and 48

  10. Change from baseline in beta-2-microglobulin to creatine ratio at Weeks 4, 8, 12, 24, and 48

    Time frame: Baseline; Weeks 4, 8, 12, 24, and 48

  11. Change from baseline in glucose at Weeks 4, 8, 12, 24, and 48

    Time frame: Baseline; Weeks 4, 8, 12, 24, and 48

  12. Change from baseline in phosphate at Weeks 4, 8, 12, 24, and 48

    Time frame: Baseline; Weeks 4, 8, 12, 24, and 48

  13. Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240

    Time frame: Weeks 48, 96, and 240

  14. Proportion of participants with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240

    Time frame: Weeks 24, 48, 96, and 240

  15. Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240

    Time frame: Weeks 24, 48, 96, and 240

  16. Composite endpoint of percentage of participants with ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240

    Time frame: Weeks 24, 48, 96 and 240

  17. Change from baseline in fibrosis as assessed by FibroTest at Weeks 24, 48, 96, and 240

    Time frame: Baseline; Weeks 24, 48, 96, and 240

  18. Percentage of participants with hepatitis B e antigen (HBeAg) loss and seroconversion to anti-HBe (HBeAG-positive participants only) at Weeks 24, 48, 96, and 240

    Time frame: Weeks 24, 48, 96, and 240

  19. Percentage of participants with composite endpoint of HBeAg seroconversion and HBV DNA < 20 IU/mL at Weeks 24, 48, 96, and 240 (in HBeAg-positive participants only)

    Time frame: Weeks 24, 48, 96, and 240

  20. Percentage of participants with composite endpoint of ALT normalization, HBeAg seroconversion and HBV DNA < 20 IU/mL at Weeks 24, 48, 96, and 240 (in HBeAg-positive participants only)

    Time frame: Weeks 24, 48, 96, and 240

  21. Percentage of participants with hepatitis B surface antigen (HBsAg) loss and seroconversion to anti-HBs at Weeks 24, 48, 96, and 240

    Time frame: Weeks 24, 48, 96, and 240

  22. Percentage of participants with qHBsAg log10 IU/mL at Weeks 24, 48, 96, and 240

    Time frame: Weeks 24, 48, 96, and 240

  23. Incidence of resistance mutations at Weeks 24, 48, 96, and 240

    Time frame: Weeks 24, 48, 96, and 240

  24. Acceptability of study drug

    Time frame: Baseline; Weeks 4, 24, and 36

    To assess acceptability of study drug, the investigator will ask participants if they were able to taste the medication on a scale of 1-5, how much they like the taste of the medication (1 = dislike very much to 5 = like very much).

  25. Palatability of study drug

    Time frame: Baseline; Weeks 4, 24, and 36

    To assess palatability of study drug, the investigator will ask participants on a scale of 0-3 how easy it was to swallow the pill (0 = poor to 3 = excellent).

  26. PK Parameter: AUCtau of tenofovir (TFV)

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  27. PK Parameter: AUClast of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  28. PK Parameter: Ctau of TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  29. PK Parameter: Cmax of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    Cmax is defined as the maximum observed concentration of drug.

  30. PK Parameter: Clast of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    Clast is defined as the last observable concentration of drug.

  31. PK Parameter: Tmax of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    Tmax is defined as the time of Cmax (the maximum concentration of drug).

  32. PK Parameter: Tlast of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    Tlast is defined as the time (observed time point) of Clast.

  33. PK Parameter: λz of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.

  34. PK Parameter: CL/F of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    CL/F is defined as the apparent oral clearance following administration of the drug.

  35. PK Parameter: Vz/F of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    Vz/F is defined as the apparent volume of distribution of the drug.

  36. PK Parameter: t1/2 of TAF and TFV

    Time frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)

    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2026
Study completion
2029
First posted
Oct 13, 2016
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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