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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

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.