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To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Tablet, P.O. 0.5, 1 mg, once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort | Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing | |
| Incidence of laboratory abnormalities of of entecavir for each cohort | Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing |
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Inclusion Criteria:
Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
ALT ≤ 10 x upper limit of normal;
Subjects must have well-compensated liver disease according to ALL of the following criteria;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Aichi-Gun | Aichi-ken | 480-1195 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20409606 | Background | Yokosuka O, Takaguchi K, Fujioka S, Shindo M, Chayama K, Kobashi H, Hayashi N, Sato C, Kiyosawa K, Tanikawa K, Ishikawa H, Masaki N, Seriu T, Omata M. Long-term use of entecavir in nucleoside-naive Japanese patients with chronic hepatitis B infection. J Hepatol. 2010 Jun;52(6):791-9. doi: 10.1016/j.jhep.2009.12.036. Epub 2010 Mar 24. | |
| 20305760 |
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| Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum | Day 1, Week 12, Week 24 and every subsequent 24 week during dosing |
| Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb) | Day 1, Week 12, Week 24 and every subsequent 24 week during dosing |
| Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48 | Day 1, Week 48 |
| Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ) | Day 1, Week 12, 24, and subsequent 24 week during dosing |
| Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion | Week 8, 16, 24 post dosing |
| Proportion of subjects negative for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ and normal ALT and remain negative for HBeAg | Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing |
| Proportion of subjects who achieved Complete Response during therapy, who have sustained Complete Response for 24 weeks after stopping drug | 24 Week post dosing |
| Proportion of subjects with histological improvement in the liver at Wks 48 & 96 [improvement in necroinflammatory score and no worsening of fibrosis at Wks 48 & 96 liver biopsy compared to baseline & to baseline in previous study] | Week 48, 96 |
| NChanges in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis | Week 48 & Week 96 |
| Incidence of genotypic changes in HBV DNA polymerase conferring resistance to entecavir in subjects with confirmed ≥1 log10 increase in HBV DNA from nadir on treatment | Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days |
| Nagoya |
| Aichi-ken |
| 457-0866 |
| Japan |
| Local Institution | Nagoya | Aichi-ken | 466-8550 | Japan |
| Local Institution | Nagoya | Aichi-ken | 467-8602 | Japan |
| Local Institution | Chiba | Chiba | Japan |
| Local Institution | Onsen-Gun | Ehime | 791-0204 | Japan |
| Local Institution | Fukuoka | Fukuoka | 814-0180 | Japan |
| Local Institution | Kurume | Fukuoka | Japan |
| Local Institution | Gifu | Gifu | 500-8513 | Japan |
| Local Institution | Ogaki-Shi | Gifu | 503-8502 | Japan |
| Local Institution | Fukuyama-Shi | Hiroshima | 721-0971 | Japan |
| Local Institution | Hiroshima | Hiroshima | 730-8518 | Japan |
| Local Institution | Hiroshima | Hiroshima | 734-0037 | Japan |
| Local Institution | Asahikawa-Shi | Hokkaido | 070-0054 | Japan |
| Local Institution | Sapporo | Hokkaido | 006-0813 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-0033 | Japan |
| Local Institution | Akashi-Shi | Hyōgo | 673-0848 | Japan |
| Local Institution | Morioka | Iwate | 020-8505 | Japan |
| Local Institution | Mitoyo-Gun | Kagawa-ken | 769-1601 | Japan |
| Local Institution | Takamatsu | Kagawa-ken | Japan |
| Local Institution | Kumamoto | Kumamoto | 860-8556 | Japan |
| Local Institution | Kyoto | Kyoto | Japan |
| Local Institution | Sendai | Miyagi | Japan |
| Local Institution | Miyazaki-Gun | Miyazaki | 889-1692 | Japan |
| Local Institution | Matsumoto | Nagano | 390-0802 | Japan |
| Local Institution | Nagasaki | Nagasaki | Japan |
| Local Institution | Omura-Shi | Nagasaki | 856-0000 | Japan |
| Local Institution | Niigata | Niigata | Japan |
| Local Institution | Oita-Gun | Oita Prefecture | 879-5503 | Japan |
| Local Institution | Kurashiki-Shi | Okayama-ken | 710-8602 | Japan |
| Local Institution | Okayama | Okayama-ken | 700-0082 | Japan |
| Local Institution | Okayama | Okayama-ken | 700-8505 | Japan |
| Local Institution | Okayama | Okayama-ken | 700-8511 | Japan |
| Local Institution | Tsuyama-Shi | Okayama-ken | 708-0841 | Japan |
| Local Institution | Kawachinagano-Shi | Osaka | 86-0008 | Japan |
| Local Institution | Osaka | Osaka | 553-0003 | Japan |
| Local Institution | Osaka | Osaka | Japan |
| Local Institution | Sakai-Shi | Osaka | 591-8025 | Japan |
| Local Institution | Suita-Shi | Osaka | Japan |
| Local Institution | Iruma-Gun | Saitama | 350-0495 | Japan |
| Local Institution | Minato-Ku | Tokyo | 105-0001 | Japan |
| Local Institution | Musashino-Shi | Tokyo | 180-0023 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 160-8582 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 162-8655 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 162-8666 | Japan |
| Local Institution | Tokyo | Tokyo | 173-8610 | Japan |
| Local Institution | Ube-Shi | Yamaguchi | 755-0067 | Japan |
| Local Institution | Nakakoma-Gun | Yamanashi | 409-3821 | Japan |
| Karino Y, Toyota J, Kumada H, Katano Y, Izumi N, Kobashi H, Sata M, Moriyama M, Imazeki F, Kage M, Ishikawa H, Masaki N, Seriu T, Omata M. Efficacy and resistance of entecavir following 3 years of treatment of Japanese patients with lamivudine-refractory chronic hepatitis B. Hepatol Int. 2010 Feb 6;4(1):414-22. doi: 10.1007/s12072-009-9162-x. |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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