Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Ulm Novartis |
---|---|
Information provided by: | University of Ulm |
ClinicalTrials.gov Identifier: | NCT00710216 |
This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B, Chronic |
Drug: Lamivudine Drug: Telbivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study) |
Estimated Enrollment: | 40 |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: Lamivudine
100 mg/day
|
B: Experimental |
Drug: Telbivudine
600 mg/day
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Universitätsklinikum Ulm ( PD Dr. med. Nektarios Dikopoulos ) |
Study ID Numbers: | EVD-001 |
Study First Received: | July 2, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00710216 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Viral kinetics Viral dynamics Telbivudine Lamivudine |
Anti-Infective Agents Liver Diseases Anti-HIV Agents Hepatitis, Chronic Hepatitis, Viral, Human Lamivudine Antiviral Agents Reverse Transcriptase Inhibitors |
Hepatitis Virus Diseases Digestive System Diseases Anti-Retroviral Agents Hepatitis B, Chronic Hepatitis B DNA Virus Infections |
Anti-Infective Agents Liver Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Hepatitis, Viral, Human Lamivudine Enzyme Inhibitors Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions |
Reverse Transcriptase Inhibitors Hepatitis Virus Diseases Digestive System Diseases Anti-Retroviral Agents Therapeutic Uses Hepatitis B, Chronic Hepatitis B DNA Virus Infections Nucleic Acid Synthesis Inhibitors |