恩替卡韦的致癌性（管理员不能删，爱妻元帅有同样标题）

大姐夫马甲

发现老外有时候也会玩点小花招，FDA认证通过了，将所有的研究都延期了，包括适应儿童用药的研究，用于肝移植后患者的应用报告也延期了。用于少数民族人群的研究也延期了，联合用药的研究也延期了。

关于于癌症的关联研究要到2016年才弄好。

竟然没有一个准时的。看来美国人有时候也人为赚钱是第一要务，不知道我分析的对不对，吃这个药物的到施贵宝网站自己看看。延期的原因都是说缺少患者用例呢，各位可以去申请一下说说自己就是案例么。

http://www.bms.com/clinical_trials/pmc/Pages/US_Commitment_Studies.aspx

ENTECAVIR	FDA PMC #1: Deferred pediatric study/substudy under PREA for the treatment of chronic hepatitis B with evidence of active liver inflammation in pediatric subjects ages from birth to 16 years of age. This study will determine the entecavir exposure (pharmacokinetics profile) for pediatric subjects ages from birth through 16 years of age to support dose-selection for the efficacy and safety assessment.	29-Mar-05	31-Jul-07	Delayed	Info
ENTECAVIR	FDA PMC #5: Conduct and submit a final study report for a larger study of efficacy and safety of entecavir in patients who are post-liver transplant. This study should enroll 50 to 100 patients and include analysis of virologic, biochemical, and serologic endpoints, evaluation of safety, and evaluation of HBV resistance.	29-Mar-05	31-Dec-08	Delayed	Info
ENTECAVIR	FDA PMC #12: Conduct and submit a final study report to evaluate the use of entecavir in treatment of chronic HBV infection in minority racial/ethnic groups that were under-represented in the pivotal clinical trials (Blacks/African Americans, Hispanics).	29-Mar-05	31-Dec-08	Delayed	Info
ENTECAVIR	FDA PMC #2: Deferred pediatric study under PREA for the treatment of chronic hepatitis B with evidence of active liver inflammation in pediatric subjects ages from birth to 16 years of age. Using doses selected based on study/substudy in postmarketing commitment 1, conduct a pediatric safety and efficacy study of entecavir with efficacy based on the results of a variety of virologic, biochemical, serologic, and composite endpoints over at least 48 weeks of dosing and safety monitored over 48 weeks.	29-Mar-05	31-Dec-09	Delayed	Info
ENTECAVIR	FDA PMC #10: Conduct and submit a final study report for a study to evaluate the safety, efficacy, and resistance profile of Entecavir used in combination with another oral anti-BV therapy in treatment-naive and treatment-experienced patients with chronic HBV to determine if there is any added benefit of combination therapy.	29-Mar-05	31-Dec-09	Delayed	Info
ENTECAVIR	FDA PMC #8: Complete and submit the final study reports for Studies 901 and 049 to obtain long-term dosing (> five-years for some subjects) and follow-up data (> five-years for some subjects) on Entecavir use in subjects rolled-over from the Phase-2 and Phase-3 clinical trials to address the following issues: * maintenance of virologic suppression; * durability of HBeAg seroconversion and the rate of new events; * risk of drug-related adverse events including malignancy; and * risk for development of resistance to entecavir.	29-Mar-05	31-Jul-11	Ongoing
ENTECAVIR	FDA PMC #3: Conduct and submit a final study report for a large simple safety study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients using entecavir compared to standard of care over a period of 5 to 10 years of follow-up. The study should be randomized, stratified according to prior treatment, and of sufficient size to detect a 30% difference in cancer outcomes between the two groups. Monitoring by an independent Data Safety Monitoring Board is recommended. Given the anticipated length of the study, it is recommended that the protocol include plans to assess the adequacy of enrollment and submit interim reports of results at yearly intervals.	29-Mar-05	31-Jul-16	Ongoing

大姐夫马甲

再详细一些的，到施贵宝的网站去看了一下：
他们将所有的恩替卡韦的研究都延期了，包括适应儿童用药的研究，用于肝移植后患者的应用报告也延期了。用于少数民族人群的研究也延期了，联合用药的研究也延期了。

竟然没有一个准时的。看来美国人有时候也人为赚钱是第一要务，不知道我分析的对不对，吃这个药物的到施贵宝网站自己看看。延期的原因都是说缺少患者用例呢，各位可以去申请一下说说自己就是案例么。

http://www.bms.com/clinical_tria ... itment_Studies.aspx



ENTECAVIR FDA PMC #1: Deferred pediatric study/substudy under PREA for the treatment of chronic hepatitis B with evidence of active liver inflammation in pediatric subjects ages from birth to 16 years of age. This study will determine the entecavir exposure (pharmacokinetics profile) for pediatric subjects ages from birth through 16 years of age to support dose-selection for the efficacy and safety assessment. 29-Mar-05 31-Jul-07 Delayed Info
ENTECAVIR FDA PMC #5: Conduct and submit a final study report for a larger study of efficacy and safety of entecavir in patients who are post-liver transplant. This study should enroll 50 to 100 patients and include analysis of virologic, biochemical, and serologic endpoints, evaluation of safety, and evaluation of HBV resistance. 29-Mar-05 31-Dec-08 Delayed Info
ENTECAVIR FDA PMC #12: Conduct and submit a final study report to evaluate the use of entecavir in treatment of chronic HBV infection in minority racial/ethnic groups that were under-represented in the pivotal clinical trials (Blacks/African Americans, Hispanics). 29-Mar-05 31-Dec-08 Delayed Info
ENTECAVIR FDA PMC #2: Deferred pediatric study under PREA for the treatment of chronic hepatitis B with evidence of active liver inflammation in pediatric subjects ages from birth to 16 years of age. Using doses selected based on study/substudy in postmarketing commitment 1, conduct a pediatric safety and efficacy study of entecavir with efficacy based on the results of a variety of virologic, biochemical, serologic, and composite endpoints over at least 48 weeks of dosing and safety monitored over 48 weeks. 29-Mar-05 31-Dec-09 Delayed Info
ENTECAVIR FDA PMC #10: Conduct and submit a final study report for a study to evaluate the safety, efficacy, and resistance profile of Entecavir used in combination with another oral anti-BV therapy in treatment-naive and treatment-experienced patients with chronic HBV to determine if there is any added benefit of combination therapy. 29-Mar-05 31-Dec-09 Delayed Info
ENTECAVIR FDA PMC #8: Complete and submit the final study reports for Studies 901 and 049 to obtain long-term dosing (> five-years for some subjects) and follow-up data (> five-years for some subjects) on Entecavir use in subjects rolled-over from the Phase-2 and Phase-3 clinical trials to address the following issues: * maintenance of virologic suppression; * durability of HBeAg seroconversion and the rate of new events; * risk of drug-related adverse events including malignancy; and * risk for development of resistance to entecavir. 29-Mar-05 31-Jul-11 Ongoing  
ENTECAVIR FDA PMC #3: Conduct and submit a final study report for a large simple safety study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients using entecavir compared to standard of care over a period of 5 to 10 years of follow-up. The study should be randomized, stratified according to prior treatment, and of sufficient size to detect a 30% difference in cancer outcomes between the two groups. Monitoring by an independent Data Safety Monitoring Board is recommended. Given the anticipated length of the study, it is recommended that the protocol include plans to assess the adequacy of enrollment and submit interim reports of results at yearly intervals. 29-M