Effectiveness and Tolerability of Eqwilate in Real-life Conditions

N/AActive Not RecruitingNCT04106908

Octapharma38 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

VWD - Von Willebrand's Disease

Interventions

EqwilateBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (9)

Caen Study Site

Caen, France

Clamart Study Site

Clamart, France

Paris Study Site - Lariboisiere

Paris, France

Paris Study Site - Necker

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: 12 months

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.

Time frame: 12 months

Occurrence of Bleeding Episodes During Follow-Up

Time frame: 12 months

Secondary Outcomes

FVIII Levels

Clotting factor VII levels in blood

Time frame: 12 months

Productivity Loss

Days lost from school or work

Time frame: 12 months

Volume of Blood loss

Time frame: up to 1 week

Immunogenicity Presence of inhibitors against VWF

Data from ClinicalTrials.gov

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