Status:
COMPLETED
Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease.
Lead Sponsor:
Corporacion Parc Tauli
Conditions:
Liver Disease Chronic
Hepatitis B Virus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Cirrhotic patients have an increased risk of infections. In these patients is important to prevent hepatitis B virus (HBV) infection, as it may cause a deterioration of liver function. How...
Detailed Description
Intervention: Serological markers of HBV will be assessed prospectively in consecutive non-cirrhotic liver disease or cirrhotic patients. Seronegative patients willing to participate will sign a writt...
Eligibility Criteria
Inclusion
- Chronic liver disease patients -non-cirrhotic and cirrhotic- diagnosed by liver biopsy and / or non-invasive methods (by standard clinical, analytical and ultrasound crite-ria)
- Negative hepatitis B surface antigen (HBs Ag) and antibody to hepatitis B core antigen (anti-HBc).
Exclusion
- Allergy to vaccine components (sodium chloride, aluminium phosphate)
- Active or past HBV infection
- Patients previously vaccinated against HBV (regardless of response)
- Child-Pugh C
- Conditions that cause immunosuppression (HIV infection, chronic renal failure, active neoplasia)
- Pregnancy or breastfeeding
- Non-immunized HAV infection.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03459521
Start Date
September 1 2017
End Date
August 1 2021
Last Update
July 11 2022
Active Locations (1)
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1
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona/Spain, Spain, 08221