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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02094430
First Posted: March 21, 2014
Last Update Posted: February 12, 2016
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.
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies
  Purpose
The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.

Condition Intervention Phase
Hypofibrinogenemia, Congenital Afibrinogenemia, Congenital Drug: biological: human fibrinogen concentrate Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Laboratoire français de Fractionnement et de Biotechnologies:

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

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

Enrollment: 16
Study Start Date: January 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FGTW Drug: biological: human fibrinogen concentrate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02094430


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

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT02094430     History of Changes
Other Study ID Numbers: FGTW-1004
First Submitted: February 26, 2014
First Posted: March 21, 2014
Last Update Posted: February 12, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn