VWD - Von Willebrand's DiseaseNCT04106908
Effectiveness and Tolerability of Eqwilate in Real-life Conditions
An observational study of VWD - Von Willebrand's Disease, run by Octapharma at 9 sites in France.
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 Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- VWD - Von Willebrand's Disease
- What is being tested?
- Eqwilate
- How many people
- 38 participants
- Where
- 9 sitesFrance
- Study dates
- 27 Nov 2019to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Caen Study Site
Caen, 14033
Clamart Study Site
Clamart, 92141
Paris Study Site - Lariboisiere
Paris, 75010
Paris Study Site - Necker
Paris, 75015
Rennes Study Site
Rennes, 35033
Rouen Study Site
Rouen, 76031
Saint Denis Study Site - Pediatrie
Saint-Denis, 97405
Saint Denis Study Site
Saint-Denis, 97405
Saint-Etienne Study Site
Saint-Etienne, 42055
About this study
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
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
- Conditions
- VWD - Von Willebrand's Disease
- Being tested
- Eqwilate
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EqwilateBiological
Eqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII
| Study group | Role | What they receive |
|---|---|---|
| Eqwilate | Not described Receives: Biological: Eqwilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Occurrence of Bleeding Episodes During Follow-Up
Occurrence of Bleeding Episodes During Follow-Up
Measured: 12 months
Secondary outcomes (4)
FVIII Levels
Clotting factor VII levels in blood
Measured: 12 months
Productivity Loss
Days lost from school or work
Measured: 12 months
Volume of Blood loss
Volume of Blood loss
Measured: up to 1 week
Immunogenicity Presence of inhibitors against VWF
Presence of inhibitors against VWF found via blood draw analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start27 Nov 2019
- Primary completion11 May 2024
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VWD - Von Willebrand's DiseaseStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106908
- Sponsor's protocol ID
- WIL-32
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04106908
- Acronym / sponsor ID
- WIL-32
- Conditions
- VWD - Von Willebrand's Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eqwilate | – | Biological: Eqwilate |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EqwilateEqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII | Biological | Eqwilate |
Primary outcome
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.
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.
Occurrence of Bleeding Episodes During Follow-Up
Time frame: 12 months
Occurrence of Bleeding Episodes During Follow-Up
4 secondary outcomes
FVIII Levels
Time frame: 12 months
Productivity Loss
Time frame: 12 months
Volume of Blood loss
Time frame: up to 1 week
Immunogenicity Presence of inhibitors against VWF
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VWD - Von Willebrand's Disease, run by Octapharma at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemostatic Effectiveness of On-demand Treatment (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.