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

F

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Completed
Phase 3

Conditions

Cirrhosis
Hepatitis B
Awaiting Organ Transplant

Treatments

Biological: HBV vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01884415
HEPATOTRAS

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Second HBV vaccination cycle
Experimental group
Description:
Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.
Treatment:
Biological: HBV vaccine
Single dose of HBV vaccine
Active Comparator group
Description:
Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination
Treatment:
Biological: HBV vaccine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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