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

January 12, 2018 updated by: CSL Behring

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Study Site
      • Edmonton, Alberta, Canada, T6G 2H7
        • Study Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Study Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • Study Site
    • Ontario
      • Hamilton, Ontario, Canada, L8S 3Z5
        • Study Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Study Site
      • Toronto, Ontario, Canada, M5G 1X8
        • Study Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Study Site
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Study Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the subject's first use of FCH, up to approximately 20 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 12 months
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2015

Primary Completion (Actual)

December 6, 2017

Study Completion (Actual)

December 6, 2017

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BI3023_4003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Fibrinogen Deficiency

Clinical Trials on FCH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe