PRELIMINARY EVALUATION OF SECURITY AND ANTIVIRAL ACTIVITY OF OPEN TREATMENT WITH ENTECAVIR IN PATIENTS WITH CHRONIC HEPATITIS B AFTER HAVING RECEIVED ENTECAVIR AS MONOTHERAPY IN OTHER CLINICAL TRIALS

BRISTOL MYERS SQUIBB COMPANY,0 个研究点目标入组 0 人开始时间: 2003年8月13日最近更新: 2023年9月4日

试验速览

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•Men and women> 16 years of age
•- Failed adefovir therapy (ie, experienced viremia according to the definition of AI463048 protocol:> 104 copies / ml of HBV serum DNA using the PCR technique and a reduction <2 log10 from baseline in the serum DNA of HBV determined by technique
•RCP) on the basis of the results of the laboratory samples of roalized or doped patients for at least 24 weeks of treatment;
•- Demonstrated intolerance to adefovir, for which both the investigator and the Central Medical Monitor of BMS agree that this prevents the continuation of adefovir treatment;
•- They have a partial response (<104 copies / ml of serum HBV DNA using the PCR technique, or a reduction> 2 logio from baseline in the serum DNA of the HBV determined by the PCR technique, with persistence of HBeAg in subjects with positive results in the visit
•baseline and / or abnormal ALT (> 1.25 X ULN)) after completing 96 weeks of therapy.

•Concomitant infection by human immunodeficiency virus (HIV).
•Therapy with nephrotoxic agents (excluding immunosuppressive agents in transplant recipients) or hepatotoxic agents, such as aminoglycosides, amphotericin B, foscamet, carbamazepine.
•Hemoglobin <11.0 g / dl (<110 g / 1) except for those coming from study AI463048. For AI463048 subjects, cases with hemoglobin <8.0 g / dl (<80 g / 1) should be consulted with the Medical Monitor.

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