- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106895
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33404
- Bordeaux Study Site
-
Le Plessis-Robinson, France, 92350
- Le Plessis Robinsin Study Site
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Marseille, France, 13285
- Marseille Study Site
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Nantes, France, 44093
- Nantes Study Site
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Valence, France, 26953
- Valence Study Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients having received Fibryga® ("on-demand" or for regular prophylaxis) in the centres participating in the study during the recollection period (limited to 7 patients by centre and by period). A total of 4 recollection periods is planned by centre.
Data from all consecutive patients having received Fibryga® whatever the indication (congenital or acquired fibrinogen deficiency; "on-demand" or regular prophylaxis) will be collected. The data collection will be limited to 7 patients by centre and by period, meaning that only data from the 7 first patients treated during the recollection period willbe collected.
Description
Inclusion Criteria:
- Patient with fibrinogen deficiency (congenital or acquired)
- Having received an treatment with Fibryga® during the recollection period
- Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse.
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fibryga
|
Fibryga
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of treatments given for an ongoing bleeding episodes
Time Frame: 6 months
|
Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
On-demand Treatment Success
Time Frame: 6 months
|
on-demand treatment of spontaneous or surgical bleeding episodes, success is defined as bleeding control (complete cessation of bleeding or < 20% decrease in hemoglobin).
|
6 months
|
Surgical Prophylaxis Success
Time Frame: 6 months
|
Surgical prophylaxis success is defined as no bleeding or oozing and control of bleeding with fibrinogen concentrate (as anticipated or requiring increased dosing or additional infusions not originally anticipated).
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FORMA-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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