Open-label, phase III, randomized, clinical trial to evaluate the efficacy of two different HBV vaccination schemes in patients with hepatic cirrhosis candidates to liver transplantation (HEPATOTRAS)

Fundación FISEVI0 个研究点开始时间: 2012年1月27日最近更新: 2012年5月23日

试验速览

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•Cirrhotic patients over 18 years old, potential candidates for liver transplantation with an estimated wait time of more than 6 months, with indication to HBV vaccionation (HBsAg negative and anti-HBs negative), who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 ?g at 0, 1 and 2 months, and who have given their consent 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 118
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Absolute contraindication to HBV vaccine.
•Medical history of allergy to any component of the vaccine.
•Chronic renal failure on hemodialysis.
•Presence of antibodies against Human Immunodeficiency Virus.
•Patients with seroconversion (anti-HBs ? 10 IU /ml) after the first three doses of vaccine.
•Lack of consent to participate in the study.

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