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
Baltimore, Maryland 21287
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Baltimore, MD
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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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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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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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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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Washington,
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