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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106895
• Other study ID #: FORMA-10
• Status: Completed
• Start date: February 21, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: May 2021
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding

Intervention

Drug:
• Fibryga
Fibryga

Locations

Country	Name	City	State
France	Bordeaux Study Site	Bordeaux
France	Le Plessis Robinsin Study Site	Le Plessis-Robinson
France	Marseille Study Site	Marseille
France	Nantes Study Site	Nantes
France	Valence Study Site	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	On-demand Treatment Success	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
Secondary	Surgical Prophylaxis Success	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