CLINICAL TRIAL WITH TENOFOVIR VERSUS LAMIVUDINE PLUS ADEFOVIR DIPIVOXIL IN LAMIVUDINE-RESISTANT CHRONIC HEPATITIS-B PATIENTS WITH UNDETECTABLE VIRAL LOAD - TENOSIMP-B

Manuel Rodríguez García0 个研究点目标入组 100 人开始时间: 2011年11月3日最近更新: 2016年6月13日

适应症

试验速览

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•? Male and female patients over 18 years of age
•? HBsAg positive at the beginning of the trial (basal visit)
•? Patients with LAM resistant Chronic Hepatitis B
•? Patients with LAM and ADV treatment for at least the last 6 months prior to the beginning of the trial
•? Patients with undetectable HBV-DNA.
•? Patients with compensated liver disease
•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 95
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•? Intolerance to any treatment component.
•? Co-infection with other viruses such as HCV, HDV or HIV.
•? Identified viral mutations associated with resistance to ADF.
•? Presence of hepatocellular carcinoma
•? Patients with severe or moderate renal failur
•? Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient?s participation during the clinical trial.
•? Pregnancy or breastfeeding.
•? Treatment within the last 30 days with any experimental (non-authorised) drug.
•?Any other disease or condition that might render the patient ineligible for the trial.

发起方

Manuel Rodríguez García