Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects



Status:Completed
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 64
Updated:7/22/2017
Start Date:September 10, 2015
End Date:October 14, 2016

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A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorerâ„¢3)

This trial is conducted globally. The aim of this trial is to investigate safety,
pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the
effect of the investigated drug on the body) of concizumab administered subcutaneously to
haemophilia A subjects.


Inclusion Criteria:

- Male subjects diagnosed with haemophilia A without inhibitors present at screening and
currently treated on-demand

- Subjects with a baseline level of factor VIII below or equal to 2 % based on medical
records

- Age between 18 and 64 years both inclusive, at the time of signing informed consent

- Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product or related products

- Platelet count below 50x10^9/L at screening

- Any clinical signs or known history of thromboembolic events, or subjects considered
at high risk of thromboembolic events as judged by the investigator

- Subjects at increased risk of cardiovascular disease as judged by the investigator
We found this trial at
9
sites
Baltimore, Maryland 21229
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Baltimore, MD
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Camperdown, New South Wales
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Camperdown,
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Iowa City, Iowa 52242
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Iowa City, IA
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Milwaukee, Wisconsin 53209
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Milwaukee, WI
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New York, New York 10029
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New York, NY
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Portland, Oregon 97239
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Portland, OR
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Torrance, California 90502
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Torrance, CA
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