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To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir (0.01 mg) | Experimental |
| |
| Entecavir (0.1 mg) | Experimental |
| |
| Entecavir (0.5 mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL) | at Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine | Through Week 24 (end of dosing) plus 5 days | |
| Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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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 |
|---|---|
| C413685 | entecavir |
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|
| Through Week 24 (end of dosing) plus 5 days |
| HBV DNA as measured by PCR (log10 copies/mL) at Week 22 [to demonstrate non-inferiority of at least one dose of entecavir as compared with lamivudine] | Week 22 |
| Proportion of subjects in each treatment group who achieve HBV DNA reduced by ≥2 log10 and/or below the limit of quantification (LOQ) (<400 copies/mL) as measured by PCR assay | Week 12, Week 22 |
| Proportion of subjects in each treatment group who achieve HBV DNA below the limit of detection (0.7 MEq/mL) of the Quantiplex branched DNA hybridization assay (Quantiplex assay) | Week 22 |
| Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN) | Week 22 |
| Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline | Baseline, Week 22 |
| Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline | Week 22 |
| Proportion of HBeAg-positive subjects at baseline who achieve responder status (defined as: HBV DNA <0.7 MEq/mL by the Quantiplex assay; loss of HBeAg and normal serum ALT) | Week 22 |
| Proportion of HBeAg-negative subjects at baseline who achieve responder status (defined as HBV DNA <0.7 MEq/mL by the Quantiplex assay and normal serum ALT) | Week 22 |
| Incidence of genotypic resistance of HBV isolates in subjects who have a ε 1 log10 increase in HBV DNA as measured by PCR assay after achieving the lowest value while on study drug | Through Week 24 |
| Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response | Week 22 |
| 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 |