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NCT01651403 · ClinicalTrials.gov registry record · Phase 3
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 of Chronic Hepatitis B, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT01651403: Active Phase 3 study of Chronic Hepatitis B, sponsored by Gilead Sciences.
NCT01651403 is a Phase 3 study of Chronic Hepatitis B that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 90 participants, below the 288-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01651403, a Phase 3 study of Chronic Hepatitis B, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT01651403 still lists
NCT01651403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 288-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (69% lower).
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.
NCT01651403 names 20 study sites across 12 states, led by Other, Arizona, California.
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.
What interventions are being tested in trial NCT01651403?
The interventions under investigation include: Tenofovir DF (DRUG), TDF Placebo (DRUG).
Who is sponsoring clinical trial NCT01651403?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01651403's enrollment target sits among peer trials
90 10th of 14 higher than 5 of 14 other Chronic Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
ACTIVE NOT RECRUITING · Phase 3
-
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
COMPLETED · Phase 3
-
A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
COMPLETED · Phase 3
-
VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
RECRUITING · Phase 2
-
Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
RECRUITING · Phase 2
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