Study whether chloroquine as comedication results in a better respons on Hepatitis B vaccination in non-responder dialysis patients.
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Titre HbsAl in both arms
Secondary outcome
NA
Background summary
Chronic dialysis patients have a risk to viarale contamination by regular
bloodcontact. The guidelines of the dutch dialysis and nefrology group avice to
preventively vaccinate all dialysispatients for hepatitis B. In clinical
pratice a lot of dialysispatients remain non-responder to the vaccination
program. Resulting in a percentage of 20-30 of the dialysis patients not
protected to a probable infection with Hepatitis B
Study objective
Study whether chloroquine as comedication results in a better respons on
Hepatitis B vaccination in non-responder dialysis patients.
Study design
Prospective, randomized intervention-study
Intervention
10 patients receive on day 1 300 mg chloroquine and on day 3 an injection of
Hbvaxpro
10 other patients receive on day 3 an injection of Hbvaxpro
At both arms after 2 weeks the titre HbsAl will be checked with 1 vial of blood
of 5 ml
Study burden and risks
Burden tablet chloroquine: by mimimale dosage minimale side-effects
Burden Hepatitis B vaccination: Pain during intramusculair injection and this
may cause haematoma.
Burden blood withdrawal: 5 ml of blood will be withdrawn out of a needle in
situ
De Run 4600
5504 DB Veldhoven
Nederland
De Run 4600
5504 DB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Chronic hemodialysis patients,
Terminated Hepatitis B vaccination programme
Anti HbAl-titier < 10 IU/l
Exclusion criteria
Myasthenia Gravis,
Rethinopathia,
Hypersensitivity of 4-aminochinolinederivates
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-001405-28-NL |
| CCMO | NL11587.000.06 |