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

NCT02932150 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GS-US-320-10922016-000785-372023-506143-42
• Study Type: interventional
• Target: 150
• Locations: 8 countries
• Sites: 39

Brief Summary

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.

Conditions

Chronic Hepatitis B

Keywords

CHB; HBV

Outcome Measures

Primary Outcomes (4)

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

  Week 24

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

  Week 24

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

  Week 24

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

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

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

Secondary Outcomes (36)

• Percentage of participants experiencing graded laboratory abnormalities

  Weeks 24, 48, 96, and 240

• Development as measured by Tanner Stage Assessment

  Weeks 24, 48, 96, and 240

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

  Baseline; Weeks 24, 48, 96, and 240

• Percentage change from baseline in BMD of lumbar spine by DXA

  Baseline; Weeks 24, 48, 96, and 240

• Change from baseline in serum creatinine

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

Study Arms (7)

TAF (Cohort 1)

EXPERIMENTAL

Participants (12 to \< 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks

Drug: TAF

Placebo (Cohort 1)

PLACEBO COMPARATOR

Participants (12 to \< 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks

Drug: Placebo

TAF (Cohort 2 Group 1)

EXPERIMENTAL

Participants (6 to \< 12 years) weighing ≥ 25 kg will receive TAF 25 mg tablet for 24 weeks

Drug: TAF

TAF (Cohort 2 Group 2)

EXPERIMENTAL

Participants (6 to \< 12 years) weighing ≥ 14 kg to \< 25 kg will receive TAF 15 mg oral granules for 24 weeks

Drug: TAF

TAF (Cohort 2 Group 3)

EXPERIMENTAL

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.

Drug: TAF

Cohort 2 Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks.

Drug: Placebo

Open-Label TAF

EXPERIMENTAL

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.

Drug: TAF

Interventions

TAF DRUG

Administered orally once daily

Open-Label TAF; TAF (Cohort 1); TAF (Cohort 2 Group 1); TAF (Cohort 2 Group 2); TAF (Cohort 2 Group 3)

Placebo DRUG

Administered orally once daily

Cohort 2 Placebo; Placebo (Cohort 1)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (39)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Rady Childrens Hospital

San Diego, California, 92123, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94158, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Texas Children's Hospital - Main Hospital

Houston, Texas, 77030, United States

Location

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Cliniques Universitaires Saint-LUC UCL

Brussels, 1200, Belgium

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Institute of Post Graduation Medical Education & Research

Kolkata, 700020, India

Location

M. V Hospital and Research Center

Lucknow, 226003, India

Location

Seth GS Medical College and KEM Hospital

Mumbai, 400012, India

Location

LTMMC & LTMG Hospital

Mumbai, 400022, India

Location

Khalatkar Hospital

Nagpur, 440009, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

SIDS Hospital and Research Centre

Surat, 395002, India

Location

Samvedna Hospital

Varanasi, 221005, India

Location

Spitalul Grigore Alexandrescu-Sectia Pediatrie III

Bucharest, 11743, Romania

Location

Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"

Bucharest, 21105, Romania

Location

Federal Research Centre of Nutrition, Biotechnology and Food Safety

Moscow, 115446, Russia

Location

Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases

Saint Petersburg, 197022, Russia

Location

Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov

Tatarstan, 420110, Russia

Location

Limited Medical Company Hepatolog

Tolyatti, 445009, Russia

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou

Taoyuan, 33305, Taiwan

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: October 13, 2016
• Study Start: November 1, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

HK (1); IN (8); US (15); RO (2); KR (3); BE (1); TW (5); RU (4)