Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT01066559
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 80 years, male or female
* Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations
* Hemodialyzed patients with hemodialysed sessions performed three times a week
* Patient able to give informed consent and affiliated to the medical insurance
Exclusion Criteria:
* Pregnant woman
* Patient never vaccinated against HBV
* Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)
* Active neoplasia or plasma cell dyscrasia
* VIH infection
* Known allergy to vaccine or to PMMA membrane
* Patient dialysed with PMMA membrane within three months before screening
* Necessity of acetate free biofiltration or hemodiafiltration as the technique of extrarenal epuration
* Vascular access problem with necessity of unipuncture for more than 30% of dialysis sessions.
* Patient under judicial protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01066559
Study Brief:
Protocol Section:
NCT01066559