Chronic Hepatitis BPhase 3NCT01651403

Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

A Phase 3 study testing Tenofovir DF in people with Chronic Hepatitis B, run by Gilead Sciences at 21 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection. Read more about this study

Who is it for?: Ages 2 to 11 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: Tenofovir DF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 21 sitesin 5 countries
Study dates: 6 Dec 2012to Jul 2027
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or Female, 2 to < 12 years of age
Weight ≥ 10 kg
Chronic HBV infection ≥ 6 months
Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
HBV Viral Load ≥ 100,000 copies/mL
Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening

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Creatinine Clearance ≥ 80 mL/min/1.73m^2
Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10 g/dL
Negative pregnancy test at screening
No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)

Who cannot join

Pregnant or lactating
Decompensated liver disease
Received interferon therapy within 6 months of screening
Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening
Alpha-fetoprotein levels > 50 ng/mL
Evidence of hepatocellular carcinoma (HCC)

Show all 11Show fewer

Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
Chronic liver disease not due to HBV
History of significant renal, cardiovascular, pulmonary, neurological or bone disease
Long term non-steroidal, anti-inflammatory drug therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

21 sites in 5 countries.

Country

City, postcode or hospital

21 sites in 5 countries

India6 sites

St. John Hospital & Medical Center
Bangalore, 560034
Medanta -The Medicity
Gurgaon, Haryana, 122 001
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
Lucknow, Uttar Pradesh, 226003
Colors Children Hospital
Nagpur, Maharashtra, 440012
Nirmal Hospital Private Limited
Surat, Gujarat, 395 002

Other trials in India

United States5 sites

Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
Phoenix Children's Hospital
Phoenix, Arizona, 85016
University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

South Korea5 sites

Kyungpook National University
Daegu, 41944
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Severance Children's Hospital
Seoul, 120-752
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Romania3 sites

Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, 011743
Fundeni Clinical Institute - Constantinesco
Bucharest, 022328
Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology
Craiova, 200515

Other trials in Romania

Taiwan2 sites

National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection

Conditions: Chronic Hepatitis B
Being tested: Tenofovir DF, TDF Placebo
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.

Tenofovir DFDrug
Also called Viread®
- Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight).
- Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.
TDF PlaceboDrug
- Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily.
- Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.

Study groups in NCT01651403
Study group	Role	What they receive
Tenofovir DF (Blinded Randomized Treatment)	Experimental	Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3). Receives: Drug: Tenofovir DF
Placebo to match TDF (Blinded Randomized Treatment)	Placebo comparator	Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3). Receives: Drug: TDF Placebo
Tenofovir DF (Open-label Treatment)	Experimental	Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3). Receives: Drug: Tenofovir DF
Tenofovir DF (Open-label Extension Phase)	Experimental	Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight. Receives: Drug: Tenofovir DF

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
Measured: Week 48
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
Measured: Week 48

Secondary outcomes (27)

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.
Measured: Week 48
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Measured: Week 48
Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Measured: Week 192
Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range.
Measured: Week 48
Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range.
Measured: Week 192
Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 48
Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 192
Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 48
Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 192
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 48
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 192
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 48
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Measured: Week 192
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
Measured: Week 48
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
Measured: Week 192
Percentage of Participants With HBsAg Loss at Week 48
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Measured: Week 48
Percentage of Participants With HBsAg Loss at Week 192
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Measured: Week 192
Percentage of Participants With HBsAg Seroconversion at Week 48
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Measured: Week 48
Percentage of Participants With HBsAg Seroconversion at Week 192
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Measured: Week 192
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48
Measured: Baseline; Week 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96
Measured: Baseline; Week 96
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144
Measured: Baseline; Week 144
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192
Measured: Baseline; Week 192
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Measured: Baseline; Week 48
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
Measured: Baseline; Week 192
Percent Change From Baseline in BMD of Spine at Week 48
Measured: Baseline; Week 48
Percent Change From Baseline in BMD of Spine at Week 192
Measured: Baseline; Week 192

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 2012Jul 2027

First posted27 Jul 2012 (estimated)
Study start6 Dec 2012
Primary completion7 Aug 2017
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01651403
Sponsor's protocol ID: GS-US-174-0144
Other IDs: 2012-000586-20, 2024-517526-26
Status last verified: Jan 2026
First submitted: 25 Jul 2012
Last updated: 30 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

(Oral Presentation) Mei-Hwei Chang, Jae Hong Park, Jorge A. Bezerra, Daniela Pacura, Sandeep Nijhawan, Byung-Ho Choe, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Tenofovir Disoproxil Fumarate (TDF) in Children with Chronic Hepatitis B (CHB). Hepatology, 2018; 68 (Suppl 1): 49A.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection
ClinicalTrials.gov ID: NCT01651403
Acronym / sponsor ID: GS-US-174-0144
Conditions: Chronic Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 90 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 6 Dec 2012 (actual)
Primary completion: 7 Aug 2017 (actual)
Study completion: Jul 2027 (estimated)
First posted: 27 Jul 2012 (estimated)
Results: Posted 19 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Tenofovir DF (Blinded Randomized Treatment)	Experimental	Drug: Tenofovir DFParticipants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
Placebo to match TDF (Blinded Randomized Treatment)	Placebo comparator	Drug: TDF PlaceboParticipants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
Tenofovir DF (Open-label Treatment)	Experimental	Drug: Tenofovir DFFollowing 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Tenofovir DF (Open-label Extension Phase)	Experimental	Drug: Tenofovir DFFollowing the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight.

Who may qualify

Ages: 2 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Male or Female, 2 to < 12 years of age
Weight ≥ 10 kg
Chronic HBV infection ≥ 6 months
Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
HBV Viral Load ≥ 100,000 copies/mL

Key exclusion criteria (11 listed)

Pregnant or lactating
Decompensated liver disease
Received interferon therapy within 6 months of screening
Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening
Alpha-fetoprotein levels > 50 ng/mL

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
Tenofovir DFAlso: Viread®* Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight). * Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.	Drug	Tenofovir DF (Blinded Randomized Treatment), Tenofovir DF (Open-label Extension Phase), Tenofovir DF (Open-label Treatment)
TDF Placebo* Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily. * Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.	Drug	Placebo to match TDF (Blinded Randomized Treatment)

Primary outcome

Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
Time frame: Week 48
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
Time frame: Week 48

27 secondary outcomes

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
Time frame: Week 48
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range
Time frame: Week 48
Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
Time frame: Week 192
Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
Time frame: Week 48
Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
Time frame: Week 192
Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
Time frame: Week 48
Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
Time frame: Week 192
Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
Time frame: Week 48
Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
Time frame: Week 192
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48
Time frame: Week 48
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192
Time frame: Week 192
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48
Time frame: Week 48
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192
Time frame: Week 192
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
Time frame: Week 48
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
Time frame: Week 192
Percentage of Participants With HBsAg Loss at Week 48
Time frame: Week 48
Percentage of Participants With HBsAg Loss at Week 192
Time frame: Week 192
Percentage of Participants With HBsAg Seroconversion at Week 48
Time frame: Week 48
Percentage of Participants With HBsAg Seroconversion at Week 192
Time frame: Week 192
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48
Time frame: Baseline; Week 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96
Time frame: Baseline; Week 96
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144
Time frame: Baseline; Week 144
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192
Time frame: Baseline; Week 192
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
Time frame: Baseline; Week 192
Percent Change From Baseline in BMD of Spine at Week 48
Time frame: Baseline; Week 48
Percent Change From Baseline in BMD of Spine at Week 192
Time frame: Baseline; Week 192

Results and safety

Results posted to the registry on 19 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tenofovir Disoproxil Fumarate	60	56
Placebo	30	25

Primary outcome: Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)

Time frame: Week 48. Number (95% Confidence Interval). Unit: percentage of participants

Measure	TDF (Blinded Randomized Phase) n = 60	Placebo (Blinded Randomized Phase) n = 29
Value	76.7 (64.0 to 86.6)	6.9 (0.8 to 22.8)

TDF (Blinded Randomized Phase) vs Placebo (Blinded Randomized Phase): p < 0.001, Cochran-Mantel-Haenszel
TDF (Blinded Randomized Phase) vs Placebo (Blinded Randomized Phase): p < 0.001, Fisher Exact

Population analysed: The Full Analysis Set (FAS) included randomized participants who have received at least 1 dose of study drug. Participants will be analyzed according to the treatment to which they were randomized. The missing equals failure approach was used where all participants with missing data were considered to have failed to achieve the endpoint.

Primary outcome: Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)

Time frame: Week 48. Number (95% Confidence Interval). Unit: percentage of participants

Measure	TDF (Blinded Randomized Phase) n = 55	Placebo (Blinded Randomized Phase) n = 26
Value	83.6 (71.2 to 92.2)	7.7 (0.9 to 25.1)

TDF (Blinded Randomized Phase) vs Placebo (Blinded Randomized Phase): p <0.001, Cochran-Mantel-Haenszel

Population analysed: Participants in the Full Analysis Set with available data were analyzed. The missing equals failure approach was used where all participants with missing data were excluded.

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TDF (Blinded Randomized Phase)	10 of 60 (16.7%)	38 of 60 (63.3%)	0 of 60
Placebo (Blinded Randomized Phase)	2 of 29 (6.9%)	16 of 29 (55.2%)	0 of 30
TDF to TDF (Open-Label Phase)	8 of 56 (14.3%)	21 of 56 (37.5%)	0 of 56
Placebo to TDF (Open-Label Phase)	3 of 25 (12%)	7 of 25 (28%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication(Oral Presentation) Mei-Hwei Chang, Jae Hong Park, Jorge A. Bezerra, Daniela Pacura, Sandeep Nijhawan, Byung-Ho Choe, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Tenofovir Disoproxil Fumarate (TDF) in Children with Chronic Hepatitis B (CHB). Hepatology, 2018; 68 (Suppl 1): 49A.
Gilead Clinical Trials WebsiteLink provided by the sponsor.

Related trials for Chronic Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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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

21 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenofovir DF in people with Chronic Hepatitis B, run by Gilead Sciences at 21 sites in 5 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 10 inclusion and 11 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in India, United States, South Korea, Romania, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach) (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01651403, which also lists 1 linked publication.

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 30 Jan 2026.