NCT01884415

Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis

Open-label, Phase III, Randomized, Clinical Trial to Evaluate the Efficacy of Two Different Hepatitis B Virus (HBV) Vaccination Schemes in Patients With Hepatic Cirrhosis Candidates to Liver Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 transplantation, who have failed seroconversion (anti-HBs \< 10 IU/ml) after three intramuscular doses of 40 µg.

Conditions

• Hepatitis B
• Cirrhosis
• Awaiting Organ Transplant

Interventions

Type	Name	Description
BIOLOGICAL	HBV vaccine	Patients receive a second cycle of vaccination
BIOLOGICAL	HBV vaccine	Patients receive vaccination according to the guidelines.

Timeline

• Start date: 2012-09-07
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-06-24
• Last updated: 2018-05-14

Locations

1 site across 1 country: Spain