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

NCT01884415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2018-05-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

HBV vaccine

Patients receive a second cycle of vaccination

BIOLOGICAL

HBV vaccine

Patients receive vaccination according to the guidelines.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Juan Manual Pascasio Acevedo, MD, PhD · Virgen del Rocío Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-07
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884415 on ClinicalTrials.gov