Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

Completed

• Conditions: Bleeding
• Interventions: Drug: Fibryga

• Registration Number: NCT04106895
• Lead Sponsor: Octapharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibryga	Fibryga	-

Primary Outcome Measures

Name	Time	Method
proportion of treatments given for an ongoing bleeding episodes	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)

Secondary Outcome Measures

Name	Time	Method
Surgical Prophylaxis Success	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).
On-demand Treatment Success	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).

Trial Locations

Locations (5)

Le Plessis Robinsin Study Site; 🇫🇷 Le Plessis-Robinson, France

Nantes Study Site; 🇫🇷 Nantes, France

Marseille Study Site; 🇫🇷 Marseille, France

Valence Study Site; 🇫🇷 Valence, France

Bordeaux Study Site; 🇫🇷 Bordeaux, France