Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
1 other identifier
observational
200
1 country
5
Brief Summary
To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2020
CompletedMay 13, 2021
May 1, 2021
12 months
August 28, 2019
May 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
proportion of treatments given for an ongoing bleeding episodes
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 Outcomes (2)
On-demand Treatment Success
6 months
Surgical Prophylaxis Success
6 months
Study Arms (1)
Fibryga
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Octapharmalead
Study Sites (5)
Bordeaux Study Site
Bordeaux, 33404, France
Le Plessis Robinsin Study Site
Le Plessis-Robinson, 92350, France
Marseille Study Site
Marseille, 13285, France
Nantes Study Site
Nantes, 44093, France
Valence Study Site
Valence, 26953, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2019
First Posted
September 27, 2019
Study Start
February 21, 2019
Primary Completion
February 10, 2020
Study Completion
February 10, 2020
Last Updated
May 13, 2021
Record last verified: 2021-05