CompletedPhase 3

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

Spain112 participantsStarted 2012-09-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Post-vaccination serological response

Timeframe: At 35 ± 5 days after administration

Trial details

NCT IDNCT01884415

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Hepatitis B trials