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Completed Phase 1Phase 2 Interventional Results available

A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

ClinicalTrials.gov ID: NCT00423891

Public ClinicalTrials.gov record NCT00423891. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 3:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied

Study identification

NCT ID
NCT00423891
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
64 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2007 (Actual)
Primary completion
Aug 31, 2013 (Actual)
Completion
Sep 4, 2017 (Actual)
Last update posted
May 2, 2018

2007 – 2017

United States locations

U.S. sites
9
U.S. states
9
U.S. cities
9
Facility City State ZIP Site status
University of California, San Francisco San Francisco California 94143 —
Connecticut Children'S Medical Center Hartford Connecticut 06106 —
University Of Florida Gainesville Florida 32610 —
Johns Hopkins School Of Medicine Baltimore Maryland 21287 —
Boston Childrens Hospital Boston Massachusetts 02115 —
Mount Sinai School Of Medicine New York New York 10029 —
Children'S Hospital Of Philadelphia Philadelphia Pennsylvania 19104 —
Rhode Island Hospital Providence Rhode Island 02903 —
University Of Texas Southwestern Medical Center Dallas Texas 75390 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00423891, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 2, 2018 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00423891 live on ClinicalTrials.gov.

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