Skip to main content

Summary

for people ages 2–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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

Keywords

Chronic Hepatitis B Virus, Pediatric Entecavir

Eligibility

For people ages 2–17

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 nucleototide 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

Locations

  • Texas Children'S Hospital
    Houston, Texas, 77030, United States
  • Indiana University School Of Medicine / Riley Hospital
    Indianapolis, Indiana, 46202, United States
  • Romero, Rene
    Atlanta, Georgia, 30322, United States
  • Local Institution
    Toronto, Ontario, M5G 1X8, Canada
  • Levine Children'S Hospital At Carolinas Medical Center
    Charlotte, North Carolina, 28203, United States
  • University Of Florida
    Gainesville, Florida, 32610, United States
  • Inova Fairfax Hospital For Children
    Fairfax, Virginia, 22031, United States
  • Children'S National Medical Center
    Washington, D.C., District of Columbia, 20010, United States
  • Johns Hopkins School Of Medicine
    Baltimore, Maryland, 21287, United States
  • Children'S Hospital Of Philadelphia
    Philadelphia, Pennsylvania, 19104, United States
  • Mount Sinai Medical Center
    New York, New York, 10029, United States
  • Connecticut Children'S Medical Center
    Hartford, Connecticut, 06106, United States
  • Rhode Island Hospital
    Providence, Rhode Island, 02903, United States
  • Boston Childrens Hospital
    Boston, Massachusetts, 02115, United States
  • Shah, Uzma
    Boston, Massachusetts, 02114, United States
  • Local Institution
    Moscow, 111123, Russian Federation
  • Local Institution
    Moscow, 117198, Russian Federation
  • Local Institution
    Novokuznetsk, 654063, Russian Federation
  • Local Institution
    St. Petersburg, 197022, Russian Federation
  • Local Institution
    London, Greater London, SE5 9RS, United Kingdom
  • Local Institution
    Birmingham, West Midlands, B4 6NH, United Kingdom
  • Local Institution
    Bruxelles, 1200, Belgium
  • Local Institution
    Daegu, 700-721, Korea, Republic of
  • Local Institution
    Seoul, 135-710, Korea, Republic of
  • Local Institution
    Seoul, 138-736, Korea, Republic of
  • Local Institution
    Mainz, Rheinland Pfalz, 55131, Germany
  • Local Institution
    Starnberg, 82319, Germany
  • Local Institution
    Wuppertal, 42283, Germany
  • Local Institution
    Bydgoszcz, 85-030, Poland
  • Local Institution
    Krakow, 31-202, Poland
  • Local Institution
    Wroclaw, 50-345, Poland
  • Local Institution
    Bunos Aires, Buenos Aires, 1425, Argentina
  • Local Institution
    Bucharest, 011743, Romania
  • Local Institution
    Iasi, 700309, Romania
  • Local Institution
    Timisoara, 300011, Romania
  • Local Institution
    Tainan, 704, Taiwan
  • Local Institution
    Taipei, 100, Taiwan
  • Local Institution
    Thesaloniki, 54635, Greece
  • Local Institution
    Beer-sheva, 84101, Israel
  • Local Institution
    Petach Tikva, Israel
  • Local Institution
    Zefat, 13110, Israel
  • Local Institution
    Guwahati, 781006, India
  • Local Institution
    Hyderabad, 500029, India

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS clinical trial educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
ID
NCT01079806
Phase
Phase 3
Lead Scientist
Philip Rosenthal
Study Type
Interventional
Last Updated
August 1, 2017