NCT01651403 is a Phase 3 clinical trial of Tenofovir DF in Chronic Hepatitis B, sponsored by Gilead Sciences.

Who is sponsoring NCT01651403?

NCT01651403 is sponsored by Gilead Sciences.

What drugs are being tested in NCT01651403?

Interventions in NCT01651403: Tenofovir DF, TDF Placebo.

What condition does NCT01651403 study?

NCT01651403 studies Chronic Hepatitis B.

Is NCT01651403 still recruiting?

NCT01651403 is currently active, enrolled. Last updated 14 January 2026.

Are results published for NCT01651403?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-14 · How we verify

NCT01651403

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Results posted Last updated 14 January 2026

What this trial tests

Phase 3 trial testing Tenofovir DF in Chronic Hepatitis B in 90 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 December 2012

Primary endpoint
7 August 2017

1 July 2027

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	6 December 2012
Primary completion	7 August 2017
Estimated completion	1 July 2027
Sites	21 locations across United States, India, Romania, South Korea, Taiwan

Drugs / interventions tested

Tenofovir DF — full drug profile →
TDF Placebo — full drug profile →

Conditions studied

Chronic Hepatitis B — all drugs for Chronic Hepatitis B →

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 2 to 11, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Tenofovir DF

Trials testing the same drug.

NCT02479880 — Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection · Phase 4 · terminated
NCT00528957 — Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children · Phase 3 · completed
NCT00078182 — Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia · Phase 2, PHASE3 · withdrawn

Other recruiting trials for Chronic Hepatitis B

Currently open trials in the same condition.

NCT07275918 — SA1211 Injection Phase 1 Study · Phase 1 · recruiting
NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07135349 — A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B · Phase 2 · active not recruiting
NCT07307586 — A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatiti · Phase 3 · recruiting
NCT07246889 — Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) · Phase 3 · active not recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01651403 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 14 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01651403.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing