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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00095121 |
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18) compared to placebo following 48 weeks of treatment.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: Adefovir Dipivoxil, |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B |
Enrollment: | 173 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
To investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18) compared to placebo following 48 weeks of treatment. To evaluate the proportion of children and adolescents who experience HBeAg and HBsAg seroconversion following 48 weeks of adefovir dipivoxil or placebo. To evaluate the development of conserved-site mutations associated with resistance to adefovir dipivoxil. To evaluate the long-term safety and efficacy in children and adolescents over an additional 4-year follow-up period including assessment of growth and renal function.
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The criteria listed below are only the main inclusion or exclusion criteria (due to limited posting capacity), a complete list will be provided by the study officials.
Key Inclusion Criteria:
Key Exclusion Criteria:
Responsible Party: | Harvard University ( Maureen Jonas ) |
Study ID Numbers: | GS-US-103-0518 |
Study First Received: | October 29, 2004 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00095121 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis B Children Pediatric Adefovir Dipivoxil |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Hepatitis B Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
Anti-Infective Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |