EUCTR2015-000557-21-ESActive, not recruitingNot Applicable
Immunogenicity and efficacy of the vaccine against Hepatitis B virus in immunosuppressed patients antiHBc positive with low titers of anti-HBs. Assessment of clinical usefulness in preventing reactivation of HBV infection. - HEPBARE
Vall de Hebron Hospital0 sitesStarted: May 28, 2015Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Age > 18 year-old.
- •2) Immunosuppressive therapy (corticosteroids, anticalcineurin, antagonists purines, mTOR inhibitors, monoclonal antibodies).
- •3) Past hepatitis B (HBsAg negative / positive antiHBc / undetectable HBV DNA) with anti-HBs titers below 100 mIU/mL.
- •4) At the time of inclusion, the patient will grant consent to participate in the study.
- •5) No exclusion criteria.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •1) Life expectancy of less than 6 months.
- •2) The following patients will be excluded due to the high risk of reactivation and the need for prophylactic treatment :
- •- AntiCD-20 monoclonal antibody (Rituximab, Ofatumumab).
- •- Chemotherapy.
- •- Transplanted hematopoietic progenitors.
- •3) Patients with allergy to any component of the vaccine.
- •4) Patients who have previously received HBV vaccination.
- •5) Patients with occult hepatitis B (HBsAg negative / antiHBc positive /detectable HBV DNA ).
- •6) Patients on renal replacement therapy with dialysis.
Investigators
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