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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01884415
Other study ID # HEPATOTRAS
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 7, 2012
Est. completion date December 2017

Study information

Verified date May 2018
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Biological:
HBV vaccine
Patients receive a second cycle of vaccination
HBV vaccine
Patients receive vaccination according to the guidelines.

Locations

Country Name City State
Spain Virgen del Rocío Hospital Seville

Sponsors (1)

Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-vaccination serological response 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. At 35 ± 5 days after administration
Secondary Association of serological response to HBV vaccination to etiology and severity of cirrhosis Etiology and severity of cirrhosis After 6 months
Secondary Association of serological response to HBV vaccination to diabetes presence Diabetes After 6 months
Secondary Association of serological response to HBV vaccination to body mass index Body mass index At baseline
Secondary Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence Presence of anti-Hepatitis B core antigen positive At baseline
Secondary Association of serological response to HBV vaccination to obesity Obesity After 6 months
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