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

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

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
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Algiers,
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
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Long Beach, California 90807
?
mi
from
Long Beach, CA
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
New Hyde Park, New York 11042
?
mi
from
New Hyde Park, NY
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
Norfolk, Virginia 23510
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
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
Phoenix, Arizona 85053
?
mi
from
Phoenix, AZ
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
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials