Chronic Hepatitis BPhase 2NCT02932150
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
A Phase 2 study testing TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 39 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 39 sitesin 8 countries
- Study dates
- Nov 2016to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
United States15 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cook Children's Medical Center
Fort Worth, Texas, 76104
Texas Children's Hospital - Main Hospital
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
Rady Childrens Hospital
San Diego, California, 92123
University of California, San Francisco (UCSF)
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
The Children's Hospital at Montefiore
The Bronx, New York, 10467
India8 sites
Institute of Post Graduation Medical Education & Research
Kolkata, 700020
M. V Hospital and Research Center
Lucknow, 226003
Seth GS Medical College and KEM Hospital
Mumbai, 400012
LTMMC & LTMG Hospital
Mumbai, 400022
Khalatkar Hospital
Nagpur, 440009
All India Institute of Medical Sciences
New Delhi, 110029
SIDS Hospital and Research Centre
Surat, 395002
Samvedna Hospital
Varanasi, 221005
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305
Russia4 sites
Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, 115446
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases
Saint Petersburg, 197022
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
Tatarstan, 420110
Limited Medical Company Hepatolog
Tolyatti, 445009
South Korea3 sites
Kyungpook National University Hospital
Daegu, 41944
Asan Medical Center
Seoul, 5505
Samsung Medical Center
Seoul, 6351
Romania2 sites
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
Bucharest, 11743
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"
Bucharest, 21105
About this study
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
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
- Being tested
- TAF, Placebo
- Keywords
- CHB, HBV
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAFDrug
Administered orally once daily
PlaceboDrug
Administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| TAF (Cohort 1) | Experimental | Participants (12 to < 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks Receives: Drug: TAF |
| Placebo (Cohort 1) | Placebo comparator | Participants (12 to < 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks Receives: 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 Receives: 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 Receives: 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. Receives: Drug: TAF |
| Cohort 2 Placebo | Placebo comparator | Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks. Receives: 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. Receives: Drug: TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24
Measured: Week 24
Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24
Measured: Week 24
Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24
Measured: 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).
Measured: 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
Measured: Weeks 24, 48, 96, and 240
Development as measured by Tanner Stage Assessment
Measured: 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)
Measured: Baseline; Weeks 24, 48, 96, and 240
Percentage change from baseline in BMD of lumbar spine by DXA
Measured: Baseline; Weeks 24, 48, 96, and 240
Change from baseline in serum creatinine
Measured: Baseline; Weeks 4, 8, 12, 24, 48, 96, and 240
Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula
Measured: Baseline; Weeks 24, 48, 96, and 240
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
Measured: Weeks 48, 96, and 240
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
Measured: Weeks 48, 96, and 240
Change from baseline in retinol-binding protein to creatine ratio at Weeks 4, 8, 12, 24, and 48
Measured: Baseline; Weeks 4, 8, 12, 24, and 48
Change from baseline in beta-2-microglobulin to creatine ratio at Weeks 4, 8, 12, 24, and 48
Measured: Baseline; Weeks 4, 8, 12, 24, and 48
Change from baseline in glucose at Weeks 4, 8, 12, 24, and 48
Measured: Baseline; Weeks 4, 8, 12, 24, and 48
Change from baseline in phosphate at Weeks 4, 8, 12, 24, and 48
Measured: Baseline; Weeks 4, 8, 12, 24, and 48
Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240
Measured: Weeks 48, 96, and 240
Proportion of participants with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240
Measured: Weeks 24, 48, 96, and 240
Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240
Measured: Weeks 24, 48, 96, and 240
Composite endpoint of percentage of participants with ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240
Measured: Weeks 24, 48, 96 and 240
Change from baseline in fibrosis as assessed by FibroTest at Weeks 24, 48, 96, and 240
Measured: Baseline; Weeks 24, 48, 96, and 240
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
Measured: Weeks 24, 48, 96, and 240
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)
Measured: Weeks 24, 48, 96, and 240
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)
Measured: Weeks 24, 48, 96, and 240
Percentage of participants with hepatitis B surface antigen (HBsAg) loss and seroconversion to anti-HBs at Weeks 24, 48, 96, and 240
Measured: Weeks 24, 48, 96, and 240
Percentage of participants with qHBsAg log10 IU/mL at Weeks 24, 48, 96, and 240
Measured: Weeks 24, 48, 96, and 240
Incidence of resistance mutations at Weeks 24, 48, 96, and 240
Measured: Weeks 24, 48, 96, and 240
Acceptability of study drug
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).
Measured: Baseline; Weeks 4, 24, and 36
Palatability of study drug
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).
Measured: Baseline; Weeks 4, 24, and 36
PK Parameter: AUCtau of tenofovir (TFV)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: 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)
PK Parameter: AUClast of TAF and TFV
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: 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)
PK Parameter: Ctau of TFV
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: 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)
PK Parameter: Cmax of TAF and TFV
Cmax is defined as the maximum observed concentration of drug.
Measured: 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)
PK Parameter: Clast of TAF and TFV
Clast is defined as the last observable concentration of drug.
Measured: 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)
PK Parameter: Tmax of TAF and TFV
Tmax is defined as the time of Cmax (the maximum concentration of drug).
Measured: 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)
PK Parameter: Tlast of TAF and TFV
Tlast is defined as the time (observed time point) of Clast.
Measured: 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)
PK Parameter: λz of TAF and TFV
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.
Measured: 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)
PK Parameter: CL/F of TAF and TFV
CL/F is defined as the apparent oral clearance following administration of the drug.
Measured: 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)
PK Parameter: Vz/F of TAF and TFV
Vz/F is defined as the apparent volume of distribution of the drug.
Measured: 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)
PK Parameter: t1/2 of TAF and TFV
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2026 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932150
- Sponsor's protocol ID
- GS-US-320-1092
- Other IDs
- 2016-000785-37, 2023-506143-42, 2023, 2016
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02932150
- Acronym / sponsor ID
- GS-US-320-1092
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB, HBV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| TAF (Cohort 1) | Experimental | Drug: TAFParticipants (12 to < 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks |
| Placebo (Cohort 1) | Placebo comparator | Drug: PlaceboParticipants (12 to < 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks |
| TAF (Cohort 2 Group 1) | Experimental | Drug: TAFParticipants (6 to < 12 years) weighing ≥ 25 kg will receive TAF 25 mg tablet for 24 weeks |
| TAF (Cohort 2 Group 2) | Experimental | Drug: TAFParticipants (6 to < 12 years) weighing ≥ 14 kg to < 25 kg will receive TAF 15 mg oral granules for 24 weeks |
| TAF (Cohort 2 Group 3) | Experimental | Drug: TAFParticipants (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. |
| Cohort 2 Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks. |
| Open-Label TAF | Experimental | Drug: TAFFollowing 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Males and non-pregnant, non-lactating females
- Weight at screening as follows:
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAFAdministered orally once daily | Drug | Open-Label TAF, TAF (Cohort 1), TAF (Cohort 2 Group 1), TAF (Cohort 2 Group 2), TAF (Cohort 2 Group 3) |
| PlaceboAdministered orally once daily | Drug | Cohort 2 Placebo, Placebo (Cohort 1) |
Primary outcome
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24
Time frame: Week 24
Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24
Time frame: Week 24
Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24
Time frame: Week 24
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).
36 secondary outcomes
Percentage of participants experiencing graded laboratory abnormalities
Time frame: Weeks 24, 48, 96, and 240
Development as measured by Tanner Stage Assessment
Time frame: 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)
Time frame: Baseline; Weeks 24, 48, 96, and 240
Percentage change from baseline in BMD of lumbar spine by DXA
Time frame: Baseline; Weeks 24, 48, 96, and 240
Change from baseline in serum creatinine
Time frame: Baseline; Weeks 4, 8, 12, 24, 48, 96, and 240
Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula
Time frame: Baseline; Weeks 24, 48, 96, and 240
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
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
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
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
Change from baseline in glucose at Weeks 4, 8, 12, 24, and 48
Time frame: Baseline; Weeks 4, 8, 12, 24, and 48
Change from baseline in phosphate at Weeks 4, 8, 12, 24, and 48
Time frame: Baseline; Weeks 4, 8, 12, 24, and 48
Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240
Time frame: Weeks 48, 96, and 240
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
Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240
Time frame: Weeks 24, 48, 96, and 240
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
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
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
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
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
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
Percentage of participants with qHBsAg log10 IU/mL at Weeks 24, 48, 96, and 240
Time frame: Weeks 24, 48, 96, and 240
Incidence of resistance mutations at Weeks 24, 48, 96, and 240
Time frame: Weeks 24, 48, 96, and 240
Acceptability of study drug
Time frame: Baseline; Weeks 4, 24, and 36
Palatability of study drug
Time frame: Baseline; Weeks 4, 24, and 36
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 39 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, India, Taiwan, Russia, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24 (time frame: Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.