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

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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.

Key facts

Study ID

NCT02137850

Run by

Novo Nordisk A/S

People needed

124

Starts

2014-06-26

Expected to finish

2023-06-07

Last updated by the study team

2025-12-23

Who can join

Age: any, up to 6. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Miller Children's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles - Endocrinology — Los Angeles, California, United States
• Children's Hosp Of Orange — Orange, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Nemours Chld Clnc Jacksonville — Jacksonville, Florida, United States
• Nemours Child Orlando Hem/Onc — Orlando, Florida, United States
• St Joseph's Hospital Foundation — Tampa, Florida, United States
• Emory University_Atlanta_1 — Atlanta, Georgia, United States
• Medical College Of Georgia — Augusta, Georgia, United States
• St. Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• Rush University Med. Cntr — Chicago, Illinois, United States
• University Of Iowa — Iowa City, Iowa, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Children's Hosp-New Orleans — New Orleans, Louisiana, United States
• Univ of NE Med Center_Omaha — Omaha, Nebraska, United States
• Hemostasis and Thrombosis Center of Nevada — Las Vegas, Nevada, United States
• Rutgers-Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• The Brooklyn Hsptl Center — Brooklyn, New York, United States
• North Shore Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Torrence Hemby Ped Hem/Onc Ctr — Charlotte, North Carolina, United States
• Novant Hlth Vasc Ins Charlotte — Charlotte, North Carolina, United States
• Univ Hosp Cleveland Med Ctr — Cleveland, Ohio, United States
• Dayton Children Hemostati Ctr — Dayton, Ohio, United States
• Arizona H&T Phoenix Child Hosp — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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