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

Afibrinogenemia, Congenital Clinical Trial

Official title:

Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094430
• Other study ID #: FGTW-1004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2014
• Last updated: February 11, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Laboratoire français de Fractionnement et de Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesLebanon: Institutional Review BoardMorocco: Ministry of Public HealthMorocco: Ethics CommitteeTurkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Afibrinogenemia
• Afibrinogenemia, Congenital
• Hypofibrinogenemia, Congenital

Intervention

Drug:
• biological: human fibrinogen concentrate

Locations

Country	Name	City	State
France	Hopital Necker enfants malades	Paris
Lebanon	Hôpital Hôtel Dieu	Beirut
Morocco	Hôpital d'enfants - CHU Avicenne	Rabat
Turkey	Faculty Ihsan Dogramaci Children's Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Countries where clinical trial is conducted

France,  Lebanon,  Morocco,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Terminal half life for Fibrinogen antigen and activity		5 days	No
Secondary	Adverse Events		Participants will be followed for the duration of their participation in the study, an expected average of 1 year	Yes