Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B



Status:Recruiting
Conditions:Hematology, Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 6
Updated:1/5/2019
Start Date:July 2, 2014
End Date:October 30, 2022
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com

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An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

This trial is conducted globally. The aim of the trial is to investigate the safety and
efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.


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 at the time of signing informed consent

- Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity
level below or equal to 2%) based on medical records or central laboratory results

- Previously untreated or exposed to FIX containing products less than or equal to 3
exposure days (5 previous exposures to blood components is acceptable)

Exclusion Criteria:

- Any history of FIX inhibitors (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 B

- 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)/LAR(s) (legally acceptable representative) mental incapacity,
unwillingness to cooperate, or a language barrier precluding adequate understanding
and cooperation
We found this trial at
14
sites
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Algiers,
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Augusta, Georgia 30912
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Baltimore, Maryland 21229
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Boise, ID
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Charlotte, North Carolina 28277
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Cleveland, Ohio 44106
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Cleveland, OH
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Dayton, OH
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Los Angeles, California 90027
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Los Angeles, CA
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Macon, Georgia 31201
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Macon, GA
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Nashville, Tennessee 37203
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Nashville, TN
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New Orleans, Louisiana 70112
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New Orleans, LA
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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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Salt Lake City, Utah 84132
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Salt Lake City, UT
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