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An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427217
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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Brief Summary:
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.

Condition or disease Intervention/treatment
Congenital Fibrinogen Deficiency Biological: FCH

Study Design
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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component
Actual Study Start Date : May 7, 2015
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Groups and Cohorts
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Group/Cohort Intervention/treatment
Fibrinogen Concentrate, Human (FCH)
A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
 Biological: FCH
FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.
Other Names:
  • Haemocomplettan® P
  • RiaSTAP®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants achieving hemostatic efficacy - retrospective [ Time Frame: From the subject's first use of FCH, up to approximately 20 years. ]
    The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.


Secondary Outcome Measures :
  1. Percentage of participants achieving hemostatic efficacy - prospective [ Time Frame: Approximately 12 months ]
    The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.

  2. Percentage of participants with adverse events [ Time Frame: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
Criteria

Inclusion Criteria:

  • Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
  • Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427217


Locations
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United States, Colorado
Study Site
Aurora, Colorado, United States, 80045
United States, Nevada
Study Site
Las Vegas, Nevada, United States, 89109
United States, North Carolina
Study Site
Durham, North Carolina, United States, 27705
Canada, Alberta
Study Site
Calgary, Alberta, Canada, T2N 2T9
Study Site
Edmonton, Alberta, Canada, T6G 2H7
Canada, Manitoba
Study Site
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Study Site
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Study Site
Hamilton, Ontario, Canada, L8S 3Z5
Study Site
Toronto, Ontario, Canada, M5B 1W8
Study Site
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Study Site
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Program Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02427217    
Other Study ID Numbers: BI3023_4003
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn