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Completed

NCT Number: NCT02094430

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

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

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Key information

Conditions

Hypofibrinogenemia, Congenital Afibrinogenemia Afibrinogenemia, Congenital Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hopital Necker enfants malades, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biological: human fibrinogen concentrate

Drug

Primary outcomes

  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 outcomes

  1. Adverse Events

    Time frame: Participants will be followed for the duration of their participation in the study, an expected average of 1 year

Sponsors and collaborators

Lead sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 21, 2014
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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