Effectiveness and Tolerability of Eqwilate in Real-life Conditions

VWD - Von Willebrand's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04106908
• Other study ID #: WIL-32
• Status: Recruiting
• Start date: November 27, 2019
• Est. completion date: September 2021

Study information

• Verified date: March 2021
• Source: Octapharma
• Contact: Mikaela Raymond
• Phone: 866-337-1868
• Email: ctgov[@]clinicalresearchmgt.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Von Willebrand Diseases
• VWD - Von Willebrand's Disease

Intervention

Biological:
• Eqwilate
Eqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII

Locations

Country	Name	City	State
France	Caen Study Site	Caen
France	Clamart Study Site	Clamart
France	Paris Study Site - Lariboisiere	Paris
France	Paris Study Site - Necker	Paris
France	Rennes Study Site	Rennes
France	Rouen Study Site	Rouen
France	Saint Denis Study Site	Saint-Denis
France	Saint Denis Study Site - Pediatrie	Saint-Denis
France	Saint-Etienne Study Site	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemostatic Effectiveness of On-demand Treatment	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.	12 months
Primary	Haemostatic Effectiveness of Perioperative Prophylaxis	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.	12 months
Primary	Occurrence of Bleeding Episodes During Follow-Up	Occurrence of Bleeding Episodes During Follow-Up	12 months
Secondary	FVIII Levels	Clotting factor VII levels in blood	12 months
Secondary	Productivity Loss	Days lost from school or work	12 months
Secondary	Volume of Blood loss	Volume of Blood loss	up to 1 week
Secondary	Immunogenicity Presence of inhibitors against VWF	Presence of inhibitors against VWF found via blood draw analysis	12 months