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

Conditions

• Chronic Hepatitis B

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• TAF — DRUG
  Administered orally once daily
• Placebo — DRUG
  Administered orally once daily

Study Details

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.

Key Dates

Start date

Nov 30, 2016

Status verified

Apr 2026

Primary completion

Sep 30, 2026

Completion

Oct 31, 2029

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TAF (Cohort 1)
  Participants (12 to \< 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks
• Placebo Comparator: Placebo (Cohort 1)
  Participants (12 to \< 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks
• Experimental: TAF (Cohort 2 Group 1)
  Participants (6 to \< 12 years) weighing ≥ 25 kg will receive TAF 25 mg tablet for 24 weeks
• Experimental: TAF (Cohort 2 Group 2)
  Participants (6 to \< 12 years) weighing ≥ 14 kg to \< 25 kg will receive TAF 15 mg oral granules for 24 weeks
• Experimental: TAF (Cohort 2 Group 3)
  Participants (2 to \< 6 years) will receive TAF for 24 weeks as follows: * weight ≥ 10 kg to \< 14 kg (7.5 mg oral granules) * weight ≥ 14 kg to \< 25 kg (15 mg oral granules) The study has reopened and recruitment is initiated only for this cohort for ≥ 10 to \< 14 kg at this time.
• Placebo Comparator: Cohort 2 Placebo
  Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks.
• Experimental: Open-Label TAF
  Following 24 weeks of blinded randomized treatment, participants will be eligible to participate in an open-label extension phase to receive TAF for an additional 216 weeks.

Primary Outcome Measure

Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24 [ Time Frame: Week 24 ]

Central Contacts

• Gilead Study Team
  [email protected]

Locations (22)

Find similar trials in Los Angeles, CA

Related Studies

• TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
  PHASE1 · Recruiting · University of Maryland, Baltimore · Baltimore, Maryland
• VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
  PHASE2 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
• Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
  PHASE2 · Recruiting · University of Maryland, Baltimore · Baltimore, Maryland
• Adaptability of an Undetectable = Untransmissible Model for HBV
  Recruiting · NYU Langone Health · New York, New York