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 |
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.
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
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