Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A



Status:Enrolling by invitation
Conditions:Hematology, Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 6
Updated:3/8/2019
Start Date:June 26, 2014
End Date:November 13, 2021

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An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

This trial is conducted globally. The aim of the trial is to investigate the safety and
efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with
haemophilia A.


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 suitability for the trial

- Male, age below 6 years of age at the time of signing informed consent

- Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records
or central laboratory results

- No prior use of purified clotting factor products (5 previous exposures to blood
components is acceptable)

Exclusion Criteria:

- Any history of FVIII inhibitor (defined by medical records) - Known or suspected
hypersensitivity to trial product or related products

- Previous participation in this trial. Participation is defined as first dose
administered of trial product

- Receipt of any investigational medicinal product within 30 days before screening

- Congenital or acquired coagulation disorder other than haemophilia A

- Any chronic disorder or severe disease which, in the opinion of the Investigator,
might jeopardise the patient's safety or compliance with the protocol

- Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity,
unwillingness to cooperate, or a language barrier precluding adequate understanding
and cooperation
We found this trial at
19
sites
Chicago, Illinois 60612
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Algiers,
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Boise, ID
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Charlotte, North Carolina 28277
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Charlotte, NC
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Dayton, OH
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Iowa City, Iowa 52242
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Iowa City, IA
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Long Beach, California 90807
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Long Beach, CA
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Los Angeles, California 90027
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Los Angeles, CA
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Nashville, Tennessee 37203
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Nashville, TN
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New Hyde Park, New York 11042
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New Hyde Park, NY
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New Orleans, Louisiana 70112
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New Orleans, LA
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Norfolk, Virginia 23510
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Norfolk, VA
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Omaha, Nebraska 68114
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Omaha, NE
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Phoenix, Arizona 85053
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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Tampa, Florida 33612
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Tampa, FL
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Torrance, California 90502
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Torrance, CA
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