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A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection - NCT00423891-06106(Clinical Trial 160208)



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City:  Hartford
State:  
CT
Zip Code: 06106
Conditions: Hepatitis B, Chronic
Purpose: 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
Study summary:
Criteria: Inclusion Criteria: - 2-18 years of age - Lamivudine native (<1 week of lamivudine) and not within 24 weeks of screening, or lamivudine experienced (>12 weeks of lamivudine) - HBV DNA ≥10*5* copies/mL - Detectable HBsAg for 24 weeks prior to screening - HBeAg positive - Compensated liver and renal function - Elevated ALT for 24 weeks prior to screening Exclusion Criteria: - Coinfection with HIV, HCV, HDV - Prior exposure to Emtricitabine (FTC) - Children who were breastfed while their mother received lamivudine, or children whose mothers received lamivudine during pregnancy
Study is available at: Connecticut Children'S Medical Center
Hartford, CT 06106
United States

Primary Contact:
Karan M. Emerick, Site 024
Phone: 860-545-9560

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 22, 2011
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