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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 17
Updated:8/2/2018
Start Date:June 30, 2010
End Date:April 3, 2018

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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

The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric
patients with chronic hepatitis B virus infection


Key Inclusion Criteria

- Males and females, aged 2 to <18 years

- Hepatitis B surface antigen-positive

- Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies

- Alanine aminotransferase (ALT) 1.5 to <10 times the upper limit of normal at screening
and within 8 to 24 weeks prior to screening

- Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening
and >100,000 copies/mL at screening

Key Exclusion Criteria

- Any prior therapy with entecavir

- At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent

- Therapy with interferon alpha, thymosin alpha, or nucleotide antiviral agents within
24 weeks of screening

- Coinfection with HIV, hepatitis C virus, or hepatitis D virus

- Decompensated liver disease

- Liver transplant recipients

- Other forms of acute and chronic conditions which may cause increased ALT levels

- Children who were breastfed while their mothers received lamivudine or whose mothers
received lamivudine during pregnancy
We found this trial at
16
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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Atlanta, Georgia 30322
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Atlanta, GA
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Baltimore, Maryland 21287
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Baltimore, MD
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Boston, Massachusetts 02114
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Boston, MA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Bunos Aires, Buenos Aires
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Bunos Aires,
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Charlotte, NC
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Fairfax, VA
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Indianapolis, IN
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San Francisco, California 94143
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San Francisco, CA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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from
Washington,
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