A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors



Status:Active, not recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:August 16, 2017
End Date:March 31, 2020

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A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under
the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A
without inhibitors.


Inclusion Criteria: - Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine the suitability for the trial - Male patients aged 18
years or older at the time of signing informed consent, diagnosed with severe haemophilia A
(FVIII activity below 1%), based on medical records or results at screening Exclusion
Criteria: - Known or suspected hypersensitivity to trial product(s) or related products -
Known inherited or acquired bleeding disorder other than haemophilia A - Presence of
inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units)
at screening measured by the Nijmegen method
We found this trial at
6
sites
Los Angeles, California 90027
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Los Angeles, CA
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Brest,
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Nashville, Tennessee 37203
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Nashville, TN
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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