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Trial record 8 of 7196 for:    vaccination

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

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ClinicalTrials.gov Identifier: NCT01884415
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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
Hepatitis B Cirrhosis Awaiting Organ Transplant Biological: HBV vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
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 : September 7, 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: HBVAXPRO 40µg HBV vaccine




Primary Outcome Measures :
  1. Post-vaccination serological response [ Time Frame: 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 [ Time Frame: After 6 months ]
    Etiology and severity of cirrhosis

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

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

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

  5. Association of serological response to HBV vaccination to obesity [ Time Frame: After 6 months ]
    Obesity



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884415


Locations
Spain
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

Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01884415     History of Changes
Other Study ID Numbers: HEPATOTRAS
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Vaccines
Hepatitis
Hepatitis B
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs