An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3b, Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B Who Have Limited Treatment Options|
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.