Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Gilead Sciences |
---|---|
Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00042393 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: Adefovir Dipivoxil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening laboratory values measured as follows, within 28 days prior to the baseline visit:
Patients who do not meet these entry criteria but for whom the treating physician believes that chronic hepatitis B disease progression or premature death is likely to occur in the absence of early access to adefovir dipivoxil will be considered on a case-by-case basis by the Parexel medical monitor.
Exclusion Criteria:
Study ID Numbers: | GS-01-550 |
Study First Received: | July 27, 2002 |
Last Updated: | March 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00042393 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis B, Chronic |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Hepatitis B Lamivudine Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
Anti-Infective Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |