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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05695560
Eligibility Criteria:
Inclusion criteria:
* Phase 1:
* Adult participants (age ≥18 years) with severe VWD (self-BAT ≥10)
* Participants who have received von Willebrand factor (VWF) treatment, either for on-demand treatment, regular prophylaxis, or situational prophylaxis (e.g., surgery) within the last 5 years
* For caregivers: Current caregiver of participants with severe VWD
* For caregivers and participants:
* Fluent in English or French
* Consent to participate in an individual phone interview and to fill self-administered questionnaires
* Additional inclusion criteria for virtual focus groups:
* Access to technology (Internet and email)
* Consent to participate in a virtual focus group with an audio recording of the session.
* Phase 2:
* Same as above for participants pediatric participants (age \<18 years) with severe VWD (self-PBQ score of ≥3 for at least one symptom).
Exclusion criteria:
* Phase 1:
* Participants or caregivers of participants who do not have severe symptoms of VWD
* Pediatric participants (age \<18 years)
* Participants who have not received any treatment (on-demand, regular or situational prophylaxis) within the last five years
* Participants who are successfully treated with desmopressin or anti-fibrinolytic medications
* Participants with inherited or acquired hemostatic or bleeding disorders other than congenital VWD (self-reported)
* Participants and caregivers of participants who show cognitive impairment (as assessed by the research nurse at the time of screening)
* Participants and caregivers who are qualified as health care practitioners currently working in a health-care capacity (e.g., physician, nurse, or healthcare aid)
* Participants or caregivers who do not reside in Canada
* Current or past participation within the last 12 months in a clinical trial
* Phase 2: Same as above excluding participants of ≥18 years of age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
50 Years
Study:
NCT05695560
Study Brief:
Protocol Section:
NCT05695560