Back to resultsHuman Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
Primary Purpose
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
biological: human fibrinogen concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Hypofibrinogenemia, Congenital
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent form by parents or a legal representative
- Age less or equal to 12 years old
- Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
- Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)
Exclusion Criteria:
- Dysfibrinogenemia
- Acquired fibrinogen deficiency
- Suspected present or past anticoagulation inhibitor
- Personal history of venous or arterial thrombosis or thromboembolic event
- Co-morbidity with other/unrelated coagulopathies
- Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
- Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.
Sites / Locations
- Hopital Necker enfants malades
- Hôpital Hôtel Dieu
- Hôpital d'enfants - CHU Avicenne
- Faculty Ihsan Dogramaci Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FGTW
Arm Description
Outcomes
Primary Outcome Measures
Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode.
Terminal half life for Fibrinogen antigen and activity
Secondary Outcome Measures
Adverse Events
Full Information
NCT ID
NCT02094430
First Posted
February 26, 2014
Last Updated
February 11, 2016
Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
1. Study Identification
Unique Protocol Identification Number
NCT02094430
Brief Title
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
Official Title
Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FGTW
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biological: human fibrinogen concentrate
Primary Outcome Measure Information:
Title
Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode.
Time Frame
6 hours or up to 5 days
Title
Terminal half life for Fibrinogen antigen and activity
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
Participants will be followed for the duration of their participation in the study, an expected average of 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent form by parents or a legal representative
Age less or equal to 12 years old
Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)
Exclusion Criteria:
Dysfibrinogenemia
Acquired fibrinogen deficiency
Suspected present or past anticoagulation inhibitor
Personal history of venous or arterial thrombosis or thromboembolic event
Co-morbidity with other/unrelated coagulopathies
Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.
Facility Information:
Facility Name
Hopital Necker enfants malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Hôtel Dieu
City
Beirut
Country
Lebanon
Facility Name
Hôpital d'enfants - CHU Avicenne
City
Rabat
Country
Morocco
Facility Name
Faculty Ihsan Dogramaci Children's Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
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