A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
NCT ID: NCT00423891
Last Updated: 2018-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2007-06-30
2017-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: Entecavir
Entecavir
Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response
Interventions
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Entecavir
Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Children who were breastfed while their mother received Lamivudine, or children whose mothers received Lamivudine during pregnancy
2 Years
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of California, San Francisco
San Francisco, California, United States
Connecticut Children'S Medical Center
Hartford, Connecticut, United States
University Of Florida
Gainesville, Florida, United States
Johns Hopkins School Of Medicine
Baltimore, Maryland, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Mount Sinai School Of Medicine
New York, New York, United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University Of Texas Southwestern Medical Center
Dallas, Texas, United States
Local Institution
Buenos Aires, , Argentina
Local Institution
Brussels, , Belgium
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Sco Paulo, São Paulo, Brazil
Local Institution
Toronto, Ontario, Canada
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Taipei, , Taiwan
Local Institution
London, Greater London, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI463-028
Identifier Type: -
Identifier Source: org_study_id
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