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Fibrinogen Concentrate (Human) - Efficacy and Safety Study | Clinical Trials | Clareo Health

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Fibrinogen Concentrate (Human) - Efficacy and Safety Study

Efficacy and Safety of Fibrinogen Concentrate (Human) (FCH) for On-demand Treatment of Acute Bleeding in Subjects With Congenital Fibrinogen Deficiency

NCT00916656•CSL Behring

View on ClinicalTrials.gov

Summary

This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human). It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution with cryoprecipitate or alternative treatments have limited safety and efficacy. The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used as a historical control.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia), expected to require treatment for bleeding
•Presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery
•Provide informed consent

Exclusion Criteria

•Life expectancy \< 6 months
•Bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia
•Treatment with any investigational medicinal product (IMP) in the 30 days prior to enrollment
•Treatment with any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to enrollment
•Treatment with any coagulation active drug (i.e., non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in 1 week prior to enrollment or as a planned or expected medication during the time period from Day 1 until 24 hours after the last FCH infusion
•Presence or history of hypersensitivity to FCH
•Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment
•Presence or history of arterial thrombosis within 1 year prior to enrollment
•Presence or history of hypersensitivity to human plasma proteins
•Presence or history of esophageal varicose bleeding
+9 more criteria

Key Dates

Start Date

October 1, 2009

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2014

Last Updated

February 6, 2023

Conditions

AfibrinogenemiaHypofibrinogenemiaFibrinogen Deficiency

Interventions

Fibrinogen Concentrate, Human (FCH)

BIOLOGICAL

Cryoprecipitate

BIOLOGICAL

Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department

NCT07097337

Trauma Induced CoagulopathyTrauma Coagulopathy+4 more

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TERMINATED

Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

NCT03793426

Congenital Fibrinogen Deficiency

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fibrinogen Concentrate (Human) - Efficacy and Safety Study

Inclusion Criteria

Exclusion Criteria

Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department

Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

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