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Eligibility
for people ages 2–18
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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

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

Keywords

Hepatitis B, Chronic Entecavir

Eligibility

You can join if…

Open to people ages 2–18

  • 2-18 years of age
  • Group A: Lamivudine naive (<1 week of Lamivudine) and not within 24 weeks of screening; Group B: Lamivudine experienced (> 12 weeks of Lamivudine); Group C:nucleoside/nucleotide experienced (> 12 weeks of nucleoside/tide therapy) added as a country-specific protocol amendment (not all sites had Group C).
  • HBV Deoxyribonucleic acid (DNA) ≥ 100000 copies/mL; ≥ 10000 copies for nucleoside/nucleotide experienced (Group C)
  • Detectable Hepatitis B surface antigen (HBsAg) for 24 weeks prior to screening
  • Hepatitis B e antigen (HBeAg) positive
  • Compensated liver and renal function
  • Elevated alanine aminotransferase (ALT) at screening and during the 24 weeks prior to screening (for Groups A and B)

You CAN'T join if...

  • Coinfection with Human immunodeficiency virus (HIV), Hepatitis C virus (HCV),Hepatitis D Virus (HDV)
  • Children who were breastfed while their mother received Lamivudine, or children whose mothers received Lamivudine during pregnancy

Locations

  • University Of Texas Southwestern Medical Center
    Dallas, Texas, 75390, United States
  • Local Institution
    Toronto, Ontario, M5G 1X8, Canada
  • University Of Florida
    Gainsville, Florida, 32610, United States
  • Johns Hopkins School Of Medicine
    Baltimore, Maryland, 21287, United States
  • Children'S Hospital Of Philadelphia
    Philadelphia, Pennsylvania, 19104, United States
  • Mount Sinai School Of Medicine
    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
  • Local Institution
    London, Greater London, SE5 9RS, United Kingdom
  • Local Institution
    Birmingham, West Midlands, B4 6NH, United Kingdom
  • Local Institution
    Porto Alegre, Rio Grande Do Sul, 90035, Brazil
  • Local Institution
    Sco Paulo, Sao Paulo, 05403, Brazil
  • Local Institution
    Bruxelles, 1200, Belgium
  • Local Institution
    Seoul, 135-710, Korea, Republic of
  • Local Institution
    Seoul, 138-736, Korea, Republic of
  • Local Institution
    Buenos Aires, 1425, Argentina
  • Local Institution
    Taipei, 100, Taiwan

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
ID
NCT00423891
Phase
Phase 1/2
Study Type
Interventional
Last Updated
January 1, 2017