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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 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.

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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

Chronic Hepatitis B

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

FieldValue
Enrollment Target 90 participants
Start Date 2012-12-06
Est. Completion 2027-07
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

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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, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (69% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.