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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT06158334
Eligibility Criteria:
Inclusion Criteria:
* patient with Haemophilia A or B
* surgery performed with Elocta® or Alprolix®
* Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors
Exclusion Criteria:
* Any blood coagulation disorder other than Haemophilia A or B
* Patient with factor VIII or IX inhibitor
* Severe liver disease (serum ALAT/ASAT levels\> 5 x ULN)
* Severe renal disease (serum creatinine \> 2x ULN)
* Known hypersensitivity to the substances or its excipients
* patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06158334
Study Brief:
Protocol Section:
NCT06158334