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Completed Phase 3 Interventional Results available

A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

ClinicalTrials.gov ID: NCT01079806

Public ClinicalTrials.gov record NCT01079806. 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 Jun 26, 2026, 6:21 AM EDT

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

Official title

A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) Versus Placebo in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive

Study identification

NCT ID
NCT01079806
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

  • Entecavir Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
2 Years to 17 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 29, 2010
Primary completion
Mar 30, 2013
Completion
Mar 30, 2018
Last update posted
May 8, 2019

2010 – 2018

United States locations

U.S. sites
15
U.S. states
14
U.S. cities
14
Facility City State ZIP Site status
University Of California, San Francisco San Francisco California 94143
Connecticut Children'S Medical Center Hartford Connecticut 06106
Children'S National Medical Center Washington D.C. District of Columbia 20010
University Of Florida Gainesville Florida 32610
Romero, Rene Atlanta Georgia 30322
Indiana University School Of Medicine / Riley Hospital Indianapolis Indiana 46202
Johns Hopkins School Of Medicine Baltimore Maryland 21287
Shah, Uzma Boston Massachusetts 02114
Boston Childrens Hospital Boston Massachusetts 02115
Mount Sinai Medical Center New York New York 10029
Levine Children'S Hospital At Carolinas Medical Center Charlotte North Carolina 28203
Children'S Hospital Of Philadelphia Philadelphia Pennsylvania 19104
Rhode Island Hospital Providence Rhode Island 02903
Texas Children'S Hospital Houston Texas 77030
Inova Fairfax Hospital For Children Fairfax Virginia 22031

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 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01079806, 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 8, 2019 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01079806 live on ClinicalTrials.gov.

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