Trial record 157 of 442 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01884415
First received: June 18, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • Post-vaccination serological response [ Time Frame: At 35 ± 5 days after administration ] [ Designated as safety issue: No ]
    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:
  • Association of serological response to HBV vaccination to other clinical variables [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
    Etiology and severity of cirrhosis

  • Association of serological response to HBV vaccination to other clinical variables [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
    Diabetes

  • Association of serological response to HBV vaccination to other clinical variables [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Body mass index

  • Association of serological response to HBV vaccination to other clinical variables [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
    Presence of anti-Hepatitis B core antigen positive

  • Association of serological response to HBV vaccination to other clinical variables [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
    Obesity


Estimated Enrollment: 44
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884415

Contacts
Contact: Clara M. Rosso Fernández, MD 0034 955 01 34 14 claram.rosso.sspa@juntadeandalucia.es
Contact: Juan Manuel Pascasio Acevedo, MD, PhD 0034 955 31 22 50 jmpascasio@gmail.com

Locations
Spain
Virgen del Rocío Hospital Recruiting
Seville, Spain, 41013
Contact: Clara M. Rosso Fernández, MD    0034 955 01 34 14    claram.rosso.sspa@juntadeandalucia.es   
Contact: Juan Manuel Pascasio Acevedo, MD, PhD    0034 955 01 22 50    jmpascasio@gmail.com   
Principal Investigator: Juan Manuel Pascasio Acevedo, MD, PhD         
Sub-Investigator: Álvaro Giraldez Gallego, MD         
Sub-Investigator: María Teresa Ferrer Ríos, MD         
Sub-Investigator: Raquel Valencia Martín, MD, PhD         
Sub-Investigator: José Manuel Sousa Martín, MD         
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
  More Information

No publications provided

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
Study First Received: June 18, 2013
Last Updated: February 13, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014