Research study in humans to compare the efficacy of two different vaccination schemes against the hepatitis B virus, in patients with chronic liver disease that are candidates for transplantation.

Conditions: HBV inmunization in patients with cirrhosis candidates for liver transplantation.
MedDRA version: 14.1Level: PTClassification code 10054130Term: Hepatitis B immunisationSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10061890Term: Organ transplantSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-005372-42-ES

Lead Sponsor: Fundación FISEVI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.