Tenofovir for the treatment of chronic hepatitis B: a study of efficacy and safety in clinical practice in NUC naive or IFN experienced patients. - Ten-B: Tenofovir DF (TDF) in chronic hepatitis B patients

OSPEDALE MAGGIORE DI MILANO (IRCCS)0 个研究点开始时间: 2008年11月24日最近更新: 2012年3月19日

研究概览

暂无简介。

• > 18 years of age  Chronic HBV infection, defined as positive serum HBsAg for at least 6 months  Serum HBV DNA  105 copies/mL for HBeAg+ve (>2000 U/ml)  Serum HBV DNA  104 copies/mL for anti-HBe+ve (>2000 U/ml)  Serum ALT  20  ULN  Hemoglobin  8 g/dL  Neutrophils  750 /mm3  Subjects NUC naive or IFN experienced.  Patients with compensated liver disease as well as patients with concomitant diseases or medications  Willing and able to provide written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study Male or females of reproductive potential who are unwilling to put into action all necessary steps to avoid pregnancy while enrolled in the study Co-infection with HCV (based on serology), HIV, or HDV Significant renal (CrCl<50 mL/min), cardiovascular, pulmonary, or neurological disease Patients with evidence of HCC with appropriate screening procedures (α fetoprotein and liver US) Currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, agents capable of modifying renal excretion Proximal tubulopathy Known hypersensitivity to the study drug (tenofovir DF) or formulation excipients

发起方

OSPEDALE MAGGIORE DI MILANO (IRCCS)