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

LFB

Status and phase: Completed; Phase 3; Phase 2

Conditions: Afibrinogenemia, Congenital; Hypofibrinogenemia, Congenital

Treatments: Drug: biological: human fibrinogen concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094430

FGTW-1004

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

FGTW

Experimental group

Treatment:

Drug: biological: human fibrinogen concentrate