A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection - NCT00423891-02115 (Clinical Trial 160211)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy160211.aspx
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Hepatitis B, Chronic |
| Purpose: |
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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
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Children'S Hospital Boston
Boston, MA 02115
United States
Primary Contact:
Maureen Jonas, Site 010
Phone: 617-355-7964
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 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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