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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-04-30

Brief Summary

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To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

Detailed Description

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The primary objective of this study is to investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

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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Hepatitis B

Interventions

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Hepsera

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have documented negative serum HBeAg with or without positive anti-HBe present at the two study visits prior to the final visit of the previous study.
* 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

* Patients who seroconvert or experience durable HBeAg loss during their participation in study GS-00-480 will not be eligible.
* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Related Links

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http://www.Gilead.com

Website for Gilead

Other Identifiers

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GS-00-481

Identifier Type: -

Identifier Source: org_study_id

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