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

NCT ID: NCT04106895

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-21

Study Completion Date

2020-02-10

Brief Summary

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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

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Conditions

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Bleeding

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fibryga

Fibryga

Intervention Type DRUG

Fibryga

Interventions

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Fibryga

Fibryga

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Octapharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bordeaux Study Site

Bordeaux, , France

Site Status

Le Plessis Robinsin Study Site

Le Plessis-Robinson, , France

Site Status

Marseille Study Site

Marseille, , France

Site Status

Nantes Study Site

Nantes, , France

Site Status

Valence Study Site

Valence, , France

Site Status

Countries

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France

Other Identifiers

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FORMA-10

Identifier Type: -

Identifier Source: org_study_id

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