Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
90actual
Sites
21
Countries
India, Romania, South Korea +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2012-12-06 | actual | When the study began enrolling |
| Primary completion | 2017-08-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2012-07-27 | estimated | When this record first appeared on the registry |
| Results posted | 2018-09-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Hepatitis B
Interventions
- Drug: Tenofovir DF — also filed as Viread®
- Drug: TDF Placebo
Primary outcomes
what the primary-completion date above is the date OFPercentage 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
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: Originalposted 2011-07-22 · 1.0 MB · Prot_000.pdf
Study Protocol: Amendment 1posted 2012-03-07 · 1.0 MB · Prot_001.pdf
Study Protocol: Amendment 2posted 2012-11-08 · 1.1 MB · Prot_002.pdf
Study Protocol: Amendment 3posted 2016-02-29 · 1.2 MB · Prot_003.pdf
Study Protocol: Amendment 4posted 2016-08-04 · 1.2 MB · Prot_004.pdf
Statistical Analysis Plan: Week 48 Analysisposted 2018-01-10 · 380 KB · SAP_005.pdf
Statistical Analysis Plan: Week 192 Analysisposted 2020-10-15 · 1.6 MB · SAP_006.pdf
Publications
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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