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

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.

Timeline

Start

2012-09-07

Primary completion

2017-12

Completion

2017-12

Publications

• Giraldez-Gallego A, Rodriguez-Seguel EDP, Valencia-Martin R, Morillo-Garcia A, Salamanca-Rivera C, Ruiz-Perez R, Cuaresma-Duque M, Rosso-Fernandez C, Ferrer-Rios MT, Sousa-Martin JM, Praena-Fernandez JM, Desongles-Corrales T, Rodriguez-Perez A, Camino-Duran F, Gasch-Illescas A, Ampuero-Herrojo J, Pascasio-Acevedo JM. Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial. Gut. 2023 Dec 7;73(1):166-174. doi: 10.1136/gutjnl-2022-328222.

Drugs

Indications