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

StatusActive, Not Recruiting
PhasePhase 3
Started2012-12-06
View on ClinicalTrials.gov ↗

Amendment history

2026-01-14
8 amendments v41-v48
8 re-verifications since 2022-01-05, no change to tracked fields
2021-06-01
Study Identification, Study Status, Conditions, Arms and Interventions, Outcome Measures, Eligibility, References, Document Section, Participant Flow, Outcome Measures (Results), Adverse Events v40
Completion date2029-11→2027-07
Eligibility criteria+55 characters
Key Inclusion Criteria: 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/ [...] vidence of hepatocellular carcinoma (HCC) Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or [...]
Secondary endpoints13 to 27 entries
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 Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range Percentage of Participants With Normalized ALT at Week 192, Based [...] [...]
Primary endpoints1 to 2 entries
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach) Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
Study title+32 characters
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fu [...]
2020-06-12
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v39
Completion date2020-05→2029-11
Secondary endpoints12 to 13 entries
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
2020-05-04
Study Status, Contacts/Locations v38
Study sitesdetails revised at 4 of 21 sites
2020-01-10
Study Status v37
Re-verified, no change to tracked fields
Show 36 earlier versions
2019-07-09
Study Identification, Study Status, Study Description, Eligibility, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v36
Completion date2030-05→2020-05
Eligibility criteria+12 characters
[...] pregnancy test at screening No prior tenofovir DF therapy (subjectsparticipants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; subjectsparticipants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; subjectsparticipants experienced on other anti-HBV nucleoside/nucleotide therapy [...] iver disease Received interferon therapy within 6 months of Screeningscreening Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of Screeningscreening Alpha-fetoprotein levels > 50 ng/mL Evidence of hepatocellu [...]
Study title+36 characters
Efficacy, Safety and Tolerability of Tenofovir DFDisoproxil Fumarate Versus Placebo in Pediatric PatientsParticipants With Chronic Hepatitis B Infection
2018-09-18
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics v35
Completion date2025-03→2030-05
Results first postednot stated→2018-09-19
Enrollment targetestimated 100→confirmed 90
Study sites23→21
Eligibility criteria+11 characters
Key Inclusion Criteria: Male or Female, 2 to < 12 years of age Weight ≥ 10kg10 kg Chronic HBV infection ≥ 6 months HBeAg-positive or HBeAg-negative HBV Viral Load ≥ 100,000 copies/mL AlaninAlanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening Creatinine Clearance ≥ 80 mL/min/1.73m^2 Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10g10 g/dL Negative pregnancy test at screening No prior tenofovir [...]
Secondary endpoints8 to 12 entries
ProportionPercentage of Participants withWith Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 ProportionPercentage of Participants withWith Normal ALT andat NormalizationWeek 48 Percentage of Participants With Normalized ALT at Week 48 Composite Endpoint of ProportionPercentage of Participants withWith HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT at Week 48 ProportionPercentage of Participants withWith HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48 ProportionsPercentage of Participants withWith HBsAg Loss Percentage andof Participants With HBsAg Seroconversion Number of Partici [...] [...]
Primary endpoints1 entry, revised
ProportionPercentage of Participants withWith Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48
Study title-15 characters
Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection
2018-01-24
Study Status, Contacts/Locations v34
Study sites21→23
2017-08-14
Study Status v33
Primary completion dateestimated 2017-08→confirmed 2017-08-07
Start date2012-12→2012-12-06
2016-12-23
Recruiting→Active, Not Recruiting Study Status, Arms and Interventions, Eligibility, Contacts/Locations v32
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2017-06→2017-08
Completion date2019-06→2025-03
Study sites36→21
Study arms2→4
Eligibility criteria+76 characters
Key Inclusion Criteria: Male or Female, 2 to < 12 years of age W [...] screening to avoid flare if randomized to the placebo arm) Key Exclusion Criteria: Pregnant or lactating Decompensated live [...] ease Long term non-steroidal, anti-inflammatory drug therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply
2016-06-30
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v31
Primary completion date2017-03→2017-06
Study sites35→36
InterventionsPlacebo to match TDF (Drug), Tenofovir DF (Drug)→TDF Placebo (Drug), Tenofovir DF (Drug)
Secondary endpoints8 entries, revised
Proportion of participantsParticipants with hepatitisHepatitis B e antigenAntigen (HBeAg) seroconversionSeroconversion at Week 7248 Proportion of Participants with Normal ALT and Normalization of ALT Composite Endpoint of Proportion of Participants with HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT Proportion of Participants with HBV DNA < 169 Copies/mL (29 IU/mL) Proportions of Participants with HBsAg Loss and Seroco [...] Cumulative Incidence of at least 4% decreaseDecrease From Baseline in Bone Mineral Density of Lumbar Spine Percent Change from baselineBaseline in boneBone mineralMineral [...]
Primary endpoints1 entry, revised
Proportion of participantsParticipants with serumSerum HBV DNA < 400 copiesCopies/mL (69 IU/mL) at weekWeek 7248
2015-12-24
Study Status, Contacts/Locations v30
Study sites33→35
2015-11-17
Study Status v29
Re-verified, no change to tracked fields
2015-10-02
Study Status v28
Primary completion date2016-11→2017-03
Completion date2019-04→2019-06
2015-08-18
Study Status, Contacts/Locations v27
Study sites32→33
2015-07-13
Study Status v26
Re-verified, no change to tracked fields
2015-06-08
Study Status, Contacts/Locations v25
Study sites31→32
2015-04-22
Study Status v24
Start date2012-09→2012-12
2015-03-18
3 amendments v21-v23
3 re-verifications since 2015-01-06, no change to tracked fields
2014-12-08
Study Status, Contacts/Locations v20
Primary completion date2016-05→2016-11
Completion date2018-11→2019-04
Study sites29→31
2014-10-27
Study Status v19
Completion date2019-03→2018-11
2014-09-16
Study Status v18
Re-verified, no change to tracked fields
2014-08-15
Study Status, Contacts/Locations v17
Study sites27→29
2014-07-16
Study Status, Contacts/Locations v16
Study sites26→27
2014-06-10
Study Status, Contacts/Locations v15
Study sites24→26
2014-05-07
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v14
InterventionsTenofovir DF (Drug), Tenofovir DF Placebo (Drug)→Placebo to match TDF (Drug), Tenofovir DF (Drug)
Secondary endpoints6 to 8 entries
Proportion of patientsparticipants with hepatitis B e antigen (HBeAg) seroconversion at Week 72 SafetyProportion of participants with normal ALT and Tolerabilitynormalization of TherapyALT BiochemicalComposite endpoint of proportion of participants with HBV DNA < 400 copies/mL and serologicalnormal responsesALT ViralGenotypic Resistancechanges from baseline within the HBV polymerase for patients who were viremic (HBV DNA > or equal 400 copies/mL) with confirmed virologic breakthrough Proportion of participants with HBV DNA < 169 copies/mL Proportion of participants with HBsAg loss and seroconv [...]
Primary endpoints1 entry, revised
Proportion of patientsparticipants with serum HBV DNA < 400 copies/mL at week 72
Study sitesdetails revised at 4 of 24 sites
2014-03-28
Study Status, Contacts/Locations v13
Primary completion date2015-09→2016-05
Completion date2018-06→2019-03
Study sites23→24
2014-02-14
Study Status, Contacts/Locations v12
Primary completion date2015-07→2015-09
Study sites22→23
2013-12-20
Study Status v11
Re-verified, no change to tracked fields
2013-11-26
Study Status, Contacts/Locations v10
Study sites20→22
2013-10-28
Study Status, Contacts/Locations v9
Study sites18→20
2013-10-15
Study Status v8
Completion date2018-03→2018-06
2013-08-22
Study Status, Eligibility, Contacts/Locations v7
Eligibility criteria+54 characters
[...] sitive or HBeAg-negative HBV Viral Load ≥ 100,000 copies/mL Alanin aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening Creatinine Clearance ≥ 80 mL/min Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10g/dL Negative pregnancy test a [...]
2013-08-16
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Study sites14→18
Eligibility criteria+101 characters
[...] eAg-negative HBV Viral Load ≥ 100,000 copies/mL ALT ≥ 1.5 x the upper limit of the normal range (ULN) at screening Creatinine Clearance ≥ 80mL80 mL/min ANC ≥ 1,500/mm^3, hemoglobin ≥ 10g/dL Negative pregnanc [...] apy within 16 weeks of Screening Alpha-fetoprotein levels > 50ng50 ng/mL Evidence of hepatocellular carcinoma (HCC) Co-infection with 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 [...]
Secondary endpoints6 entries, revised
Proportion of patients with hepatitis B e antigen (HBeAg) seroconversion at weekWeek 72
2013-06-05
Study Status, Contacts/Locations v5
Study sites13→14
2013-02-11
Study Status, Contacts/Locations v4
Completion date2017-12→2018-03
Study sites8→13
2012-12-12
Study Status, Contacts/Locations v3
Study sites5→8
2012-11-26
Study Status, Contacts/Locations v2
Study sites1→5
2012-10-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2012-08→2012-09
Study sites0→1
2012-07-25
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT01651403
Lead Sponsor Gilead Sciences
Conditions Chronic Hepatitis B
Enrollment 90 participants
Start Date 2012-12-06
Primary Completion 2017-08-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-30