Status:
COMPLETED
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Hepatitis B
Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver tran...
Eligibility Criteria
Inclusion
- Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
- Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
- Patients over 18 years old.
- Negative pregnancy test.
- Patients who have given their consent to participate in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
September 7 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01884415
Start Date
September 7 2012
End Date
December 1 2017
Last Update
May 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virgen del Rocío Hospital
Seville, Spain, 41013