Effectiveness and Tolerability of Eqwilate in Real-life Conditions

• Conditions: VWD - Von Willebrand's Disease
• Interventions: Biological: Eqwilate

• Registration Number: NCT04106908
• Lead Sponsor: Octapharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Study Start: 2019-11-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-05
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 47

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.

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eqwilate	Eqwilate	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Bleeding Episodes During Follow-Up	12 months	Occurrence of Bleeding Episodes During Follow-Up
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.
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.

Secondary Outcome Measures

Name	Time	Method
FVIII Levels	12 months	Clotting factor VII levels in blood
Immunogenicity Presence of inhibitors against VWF	12 months	Presence of inhibitors against VWF found via blood draw analysis
Productivity Loss	12 months	Days lost from school or work
Volume of Blood loss	up to 1 week	Volume of Blood loss

Trial Locations

Locations (9)

Caen Study Site; 🇫🇷 Caen, France

Clamart Study Site; 🇫🇷 Clamart, France

Rennes Study Site; 🇫🇷 Rennes, France

Paris Study Site - Lariboisiere; 🇫🇷 Paris, France

Paris Study Site - Necker; 🇫🇷 Paris, France

Rouen Study Site; 🇫🇷 Rouen, France

Saint Denis Study Site - Pediatrie; 🇫🇷 Saint-Denis, France

Saint-Etienne Study Site; 🇫🇷 Saint-Étienne, France

Saint Denis Study Site; 🇫🇷 Saint-Denis, France