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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug | 100 mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy | 12 weeks | |
| Influence of HBeAg status to the decrease in viral load | 12 weeks | |
| Influence of HBV genotype to the decrease in viral load |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nektarios Dikopoulos, MD | University Hospital Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ulm | Ulm | 89081 | Germany |
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| Label | URL |
|---|---|
| University Hospital Ulm | View source |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| C050016 | lipoarabinomannan |
| D000077712 | Telbivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Telbivudine | Drug | 600 mg/day |
|
|
| 12 weeks |
| Change in ALT and AST levels from Baseline to Week 12 | 12 weeks |
| Development of viral resistance and treatment failure during the study and subsequent course of observation | 6 month |
| Safety assessed by adverse events and laboratory values | 6 month |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |