MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Octapharma
- Enrollment
- 38
- Locations
- 9
- Primary Endpoint
- Occurrence of Bleeding Episodes During Follow-Up
Study Overview
Brief Summary
MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened. Patients will be of any VWD type, previously treated or untreated.
Exclusion Criteria
- Not provided
Arms & Interventions
Eqwilate
Intervention: Eqwilate (Biological)
Outcomes
Primary Outcomes
Occurrence of Bleeding Episodes During Follow-Up
Time Frame: 12 months
Occurrence of Bleeding Episodes During Follow-Up
Haemostatic Effectiveness of Perioperative Prophylaxis
Time Frame: 12 months
Haemostatic Effectiveness of Perioperative Prophylaxis (excellent, good, moderate, none) none: severe uncontrolled bleeding or intensity of bleeding not changed (in case of non-severe bleeding episodes); moderate: moderate bleeding, or control of bleeding required additional product; good: slight oozing and adequate control of bleeding episode and did not require additional product; excellent: haemostasis achieved, cessation of bleeding episode.
Haemostatic Effectiveness of On-demand Treatment
Time Frame: 12 months
Haemostatic Effectiveness of On-demand Treatment (excellent, good, moderate, none) none: severe uncontrolled bleeding or intensity of bleeding not changed (in case of non-severe bleeding episodes); moderate: moderate bleeding, or control of bleeding required additional product; good: slight oozing and adequate control of bleeding episode and did not require additional product; excellent: haemostasis achieved, cessation of bleeding episode.
Secondary Outcomes
- FVIII Levels(12 months)
- Immunogenicity Presence of inhibitors against VWF(12 months)
- Productivity Loss(12 months)
- Volume of Blood loss(up to 1 week)