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

Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)
Overall Status
Completed
CT.gov ID
NCT01884415
Collaborator
(none)
112
Enrollment
1
Location
2
Arms
62.8
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: HBV vaccine
  • Biological: HBV vaccine
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 7, 2012
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Second HBV vaccination cycle

Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.

Biological: HBV vaccine
Patients receive a second cycle of vaccination
Other Names:
  • HBVAXPRO 40µg HBV vaccine

    		•
    Active Comparator: Single dose of HBV vaccine

    Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination

    Biological: HBV vaccine
    Patients receive vaccination according to the guidelines.
    Other Names:
  • HBVAXPRO 40µg HBV vaccine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-vaccination serological response [At 35 ± 5 days after administration]

      To compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg at 0, 1 and 2 months.

    Secondary Outcome Measures

    1. Association of serological response to HBV vaccination to etiology and severity of cirrhosis [After 6 months]

      Etiology and severity of cirrhosis

    2. Association of serological response to HBV vaccination to diabetes presence [After 6 months]

      Diabetes

    3. Association of serological response to HBV vaccination to body mass index [At baseline]

      Body mass index

    4. Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence [At baseline]

      Presence of anti-Hepatitis B core antigen positive

    5. Association of serological response to HBV vaccination to obesity [After 6 months]

      Obesity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).

    2. 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.

    3. Patients over 18 years old.

    4. Negative pregnancy test.

    5. Patients who have given their consent to participate in the study.

    Exclusion Criteria:

    1. Absolute contraindication to HBV vaccine.

    2. Medical history of allergy to any component of the vaccine.

    3. Chronic renal failure on hemodialysis.

    4. Presence of antibodies against Human Immunodeficiency Virus.

    5. Patients with seroconversion (anti-HBs > 10 IU /ml) after the first three doses of vaccine.

    6. Lack of consent to participate in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virgen del Rocío Hospital Seville Spain 41013

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Juan Manual Pascasio Acevedo, MD, PhD, Virgen del Rocío Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    ClinicalTrials.gov Identifier:
    NCT01884415
    Other Study ID Numbers:
    • HEPATOTRAS
    First Posted:
    Jun 24, 2013
    Last Update Posted:
    May 14, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis
    Liver Cirrhosis
    Fibrosis
    Vaccines

    Study Results

    No Results Posted as of May 14, 2018