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

Use our guide to learn which trials are right for you!

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
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Algiers,
Click here to add this to my saved trials
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21229
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials