Effectiveness and Tolerability of Eqwilate in Real-life Conditions

March 4, 2021 updated by: Octapharma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Not yet recruiting
        • Caen Study Site
      • Clamart, France, 92141
        • Not yet recruiting
        • Clamart Study Site
      • Paris, France, 75010
        • Not yet recruiting
        • Paris Study Site - Lariboisiere
      • Paris, France, 75015
        • Not yet recruiting
        • Paris Study Site - Necker
      • Rennes, France, 35033
        • Recruiting
        • Rennes Study Site
      • Rouen, France, 76031
        • Not yet recruiting
        • Rouen Study Site
      • Saint-Denis, France, 97405
        • Not yet recruiting
        • Saint Denis Study Site - Pediatrie
      • Saint-Denis, France, 97405
        • Not yet recruiting
        • Saint Denis Study Site
      • Saint-Étienne, France, 42055
        • Not yet recruiting
        • Saint-Etienne Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eqwilate
Biological: Eqwilate
Eqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Occurrence of Bleeding Episodes During Follow-Up
Time Frame: 12 months
Occurrence of Bleeding Episodes During Follow-Up
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FVIII Levels
Time Frame: 12 months
Clotting factor VII levels in blood
12 months
Productivity Loss
Time Frame: 12 months
Days lost from school or work
12 months
Volume of Blood loss
Time Frame: up to 1 week
Volume of Blood loss
up to 1 week
Immunogenicity Presence of inhibitors against VWF
Time Frame: 12 months
Presence of inhibitors against VWF found via blood draw analysis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Octapharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIL-32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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