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Clinical Trial Summary

The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to its commercial availability to people with lamivudine-resistant chronic hepatitis B who have limited treatment options.


Clinical Trial Description

Due to the considerable unmet medical need of patients with chronic hepatitis B, Gilead has initiated an early access program to make its investigational drug, adefovir dipivoxil 10 mg, available to those patients with lamivudine-resistant chronic hepatitis B at risk of disease progression. Protocol GS-01-550 provides access to patients with lamivudine-resistant hepatitis B virus who are in need of an alternative treatment to suppress HBV DNA replication and prevent progressive liver disease. ;


Study Design

N/A


Related Conditions & MeSH terms


NCT number NCT00042393
Study type Expanded Access
Source Gilead Sciences
Contact
Status Approved for marketing
Phase Phase 3

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