Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-02 @ 6:44 AM
Study NCT ID:
NCT00042393
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2014-01-07
First Post:
2002-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
Sponsor:
Gilead Sciences
Organization:
Study Overview
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
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: