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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884415
• Other study ID #: HEPATOTRAS
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Awaiting Organ Transplant
• Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis B
• Liver Cirrhosis

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