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A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic HBV-Infection - NCT01079806-21287(Clinical Trial 618909)



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City:  Baltimore
State:  
MD
Zip Code: 21287
Conditions: Chronic Hepatitis B Virus, Pediatric
Purpose: The purpose of this study is to determine the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B infection
Study summary:
Criteria: Inclusion Criteria: - 2 - < 18 years of age, male or female - HBsAg-positive - Detectable HBeAg, and no detectable anti-HBe antibodies - ALT 1.5 - <10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening - Evidence of the presence of HBV DNA at least 4 weeks before screening and > 100,000 copies/mL at screening Exclusion: - Any prior therapy with ETV - > 12 weeks of prior therapy with any nucleoside or nucleotide antiviral aget - Therapy with interferon alpha, thymosin alpha, or nucletos[t]ide antiviral agents within 24 weeks of screening - Coinfection with HIV, HCV, HDV - Decompensated liver disease - Liver transplant recipients - Other forms of acute and chronic conditions which may cause increased ALT - Children who were breastfed while their mother received lamivudine, or children whose mother received lamivudine during pregnancy
Study is available at: Johns Hopkins School Of Medicine
Baltimore, MD 21287
United States

Primary Contact:
Kathleen B Schwarz, Site 003
Phone: 410-955-8769

Secondary Contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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