Prevention of HBV reinfection after liver transplantation using entecavir monotherapy after short-term HBIg administration: A pilot studyVersion 1.2 2008-09-11Amendment 2 2009-07-07

Hannover Medical School0 个研究点目标入组 20 人开始时间: 2009年4月7日最近更新: 2022年5月9日

适应症

试验速览

暂无简介。

•liver transplantation for hepatitis B-induced end.stage liver disease
•Absence of coinfection with HIV and HCV
•Female and male patients > 18 years of age
•renal function as measured by estimated creatine clearance >30ml/min
•patients who received a short-term HBIG administration for 4 weeks after liver transplantation
•the patient is willing ans able to provide written informed concent to participate in the study
•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

•Any evidence of other causes for end-stage liver disease (e. g. autoimmune hepatitis, hepatitis C, hereditary liver disease,...); Patients that do not fulfil criteria for liver transplantation; Patients with a history or evidence of any intolerance or hypersensitivity to any of the study drugs; Patients with impaired renal function (creatine clearance <30ml/min); Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malsbsorption; Patients who are pregnant or nursing; Co-administration of tenofovir and other medical products containing tenofovir disoproxil fumarate, adefovir dipivixil, didanosine, nephrotoxic medical products; Inability to comply with study procedures; current participation in any other clinical trial.

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