Effectiveness and Tolerability of Eqwilate in Real-life Conditions
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Eqwilate
|
Biological: Eqwilate
Eqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII
|
Outcome Measures
Primary Outcome Measures
- Haemostatic Effectiveness of On-demand Treatment [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.
- Haemostatic Effectiveness of Perioperative Prophylaxis [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.
- Occurrence of Bleeding Episodes During Follow-Up [12 months]
Occurrence of Bleeding Episodes During Follow-Up
Secondary Outcome Measures
- FVIII Levels [12 months]
Clotting factor VII levels in blood
- Productivity Loss [12 months]
Days lost from school or work
- Volume of Blood loss [up to 1 week]
Volume of Blood loss
- Immunogenicity Presence of inhibitors against VWF [12 months]
Presence of inhibitors against VWF found via blood draw analysis
Eligibility Criteria
Criteria
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:
- N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Caen Study Site | Caen | France | 14033 | |
| 2 | Clamart Study Site | Clamart | France | 92141 | |
| 3 | Paris Study Site - Lariboisiere | Paris | France | 75010 | |
| 4 | Paris Study Site - Necker | Paris | France | 75015 | |
| 5 | Rennes Study Site | Rennes | France | 35033 | |
| 6 | Rouen Study Site | Rouen | France | 76031 | |
| 7 | Saint Denis Study Site - Pediatrie | Saint-Denis | France | 97405 | |
| 8 | Saint Denis Study Site | Saint-Denis | France | 97405 | |
| 9 | Saint-Etienne Study Site | Saint-Étienne | France | 42055 |
Sponsors and Collaborators
- Octapharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WIL-32