Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.
NCT ID: NCT00158717
Last Updated: 2014-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
107 participants
OBSERVATIONAL
2003-04-30
2006-04-30
Brief Summary
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Detailed Description
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The secondary objective of this study is to investigate the durability of HBeAg loss in patients with chronic hepatitis B virus infection (HBV) who have experienced durable HBeAg loss while participating in a previous Gilead-sponsored study of adefovir dipivoxil.
Conditions
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Interventions
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Hepsera
Eligibility Criteria
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Inclusion Criteria
* A patient who has documented negative serum HBeAg without positive anti-HBe must also have undetectable serum HBV DNA (less than 1000 copies/mL using Roche Amplicor PCR Assay) and normalized ALT (less than ULN) confirmed during these two studies.
* All patients must be able to give written informed consent and comply with requirements of this study.
Exclusion Criteria
* Any serious or active medical or psychiatric illness that, in the opinion of the investigator would interfere with patient treatment, assessment or compliance with the protocol.
* Receiving any of the excluded medications listed in the protocol.
* Inability to comply with study requirements.
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Related Links
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Website for Gilead
Other Identifiers
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GS-00-481
Identifier Type: -
Identifier Source: org_study_id
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