Effectiveness and Tolerability of Eqwilate in Real-life Conditions

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04106908

Enrollment

Registered

2019-09-27

Start date

2019-11-27

Completion date

2026-11-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VWD - Von Willebrand's Disease

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

Interventions

BIOLOGICALEqwilate

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026