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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02094430
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypofibrinogenemia, Congenital Afibrinogenemia, Congenital Drug: biological: human fibrinogen concentrate Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: FGTW Drug: biological: human fibrinogen concentrate

Primary Outcome Measures :
  1. 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 ]
  2. Terminal half life for Fibrinogen antigen and activity [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Participants will be followed for the duration of their participation in the study, an expected average of 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02094430

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Hopital Necker enfants malades
Paris, France, 75015
Hôpital Hôtel Dieu
Beirut, Lebanon
Hôpital d'enfants - CHU Avicenne
Rabat, Morocco
Faculty Ihsan Dogramaci Children's Hospital
Ankara, Turkey
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies

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Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies Identifier: NCT02094430    
Other Study ID Numbers: FGTW-1004
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn