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NCT Number: NCT04106908

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

VWD - Von Willebrand's Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen Study Site, Caen, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eqwilate

Biological

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

Primary outcomes

  1. Haemostatic Effectiveness of On-demand Treatment

    Time frame: 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.

  2. Haemostatic Effectiveness of Perioperative Prophylaxis

    Time frame: 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.

  3. Occurrence of Bleeding Episodes During Follow-Up

    Time frame: 12 months

    Occurrence of Bleeding Episodes During Follow-Up

Secondary outcomes

  1. FVIII Levels

    Time frame: 12 months

    Clotting factor VII levels in blood

  2. Productivity Loss

    Time frame: 12 months

    Days lost from school or work

  3. Volume of Blood loss

    Time frame: up to 1 week

    Volume of Blood loss

  4. Immunogenicity Presence of inhibitors against VWF

    Time frame: 12 months

    Presence of inhibitors against VWF found via blood draw analysis

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Sep 27, 2019
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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