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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
NCT01651403 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Tenofovir DF
- DRUG TDF Placebo
Study Locations (20)
Other
- St. John Hospital & Medical Center — Bangalore
- Grigore Alexandrescu Emergency Clinical Hospital for Children — Bucharest
- Fundeni Clinical Institute - Constantinesco — Bucharest
- Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology — Craiova
- Kyungpook National University — Daegu
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- Severance Children's Hospital — Seoul
- National Taiwan University Hospital — Taipei
Arizona
- Phoenix Children's Hospital — Phoenix
California
- University of California, San Francisco — San Francisco
Colorado
- Children's Hospital Colorado — Aurora
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Texas
- Texas Children's Hospital — Houston
Gujarat
- Nirmal Hospital Private Limited — Surat
Haryana
- Medanta -The Medicity — Gurgaon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2012-12-06 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01651403
The ClinicalTrials.gov registry entry for NCT01651403 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 2 interventions — of which Tenofovir DF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01651403 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01651403 about?
NCT01651403 is a clinical study titled "Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection". 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.
What is the current status of trial NCT01651403?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2012-12-06. Estimated completion is 2027-07.
What conditions does trial NCT01651403 study?
This clinical trial studies the following conditions: Chronic Hepatitis B. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01651403?
The interventions under investigation include: Tenofovir DF (DRUG), TDF Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01651403?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01651403 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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