Clinical trial

Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Name

2012/251-31/2

Description

CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

Trial arms

Trial start

2015-09-01

Estimated PCD

2023-12-01

Trial end

2025-12-31

Status

Withdrawn

Treatment

Vaccination with vaccine against hepatitis A and B

Vaccination against hepatitis A and B

Arms:

Cystic Fibrosis, Healthy volunteers

Other names:

Twinrix (TM)

Primary endpoint

Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers

6 months for vaccination

Eligibility criteria

Inclusion Criteria: * CF patients not previously immunized against hepatitis A or B * Healthy volunteers not previously immunized against hepatitis A or B * Age over 1 year Exclusion Criteria: * Previously transplanted patients * Previous vaccination with hepatitis vaccine * Known allergy against components in Twinrix (TM)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-03-18

1 organization

1 product

4 indications

Organization

Karolinska University Hospital

Product

Vaccination against Hepatitis A and B

Indication

Indication

Indication

Indication