Trial record 4 of 6 for:    "Afibrinogenemia"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Laboratoire français de Fractionnement et de Biotechnologies
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier:
NCT02094430
First received: February 26, 2014
Last updated: March 20, 2014
Last verified: February 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Terminal half life for Fibrinogen antigen and activity [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: January 2014
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FGTW Drug: biological: human fibrinogen concentrate

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094430

Contacts
Contact: Eric NEUHART, MD 33 (0) 1 69 82 70 87

Locations
France
Hopital Necker enfants malades Not yet recruiting
Paris, France, 75015
Lebanon
Hôpital Hôtel Dieu Recruiting
Beirut, Lebanon
Morocco
Hôpital d'enfants - CHU Avicenne Not yet recruiting
Rabat, Morocco
Turkey
Faculty Ihsan Dogramaci Children's Hospital Not yet recruiting
Ankara, Turkey
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
  More Information

No publications provided

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT02094430     History of Changes
Other Study ID Numbers: FGTW-1004
Study First Received: February 26, 2014
Last Updated: March 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Lebanon: Institutional Review Board
Morocco: Ministry of Public Health
Morocco: Ethics Committee
Turkey: Ethics Committee
Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014