Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency

Phase 2

Completed

• Conditions: Hypofibrinogenemia, Congenital; Afibrinogenemia, Congenital

• Registration Number: NCT02094430
• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Brief Summary

The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode.	6 hours or up to 5 days
Terminal half life for Fibrinogen antigen and activity	5 days

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Participants will be followed for the duration of their participation in the study, an expected average of 1 year

Trial Locations

Locations (4)

Hôpital d'enfants - CHU Avicenne; 🇲🇦 Rabat, Morocco

Faculty Ihsan Dogramaci Children's Hospital; 🇹🇷 Ankara, Turkey

Hôpital Hôtel Dieu; 🇱🇧 Beirut, Lebanon

Hopital Necker enfants malades; 🇫🇷 Paris, France