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

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia B

In brief

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.

Key facts

Study ID

NCT02141074

Run by

Novo Nordisk A/S

People needed

54

Starts

2014-07-02

Expected to finish

2022-10-27

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 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)

You may not qualify if…

• 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

Where it is running

• Children's Hospital Los Angeles - Endocrinology — Los Angeles, California, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Nemours Chld Clnc Jacksonville — Jacksonville, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Hope for Kids — Macon, Georgia, United States
• St. Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• University Of Iowa — Iowa City, Iowa, United States
• Children's Hosp-New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins University_Baltimore_3 — Baltimore, Maryland, United States
• Univ of NE Med Center_Omaha — Omaha, Nebraska, United States
• North Shore Long Island Jewish Medical Center — New Hyde Park, New York, United States
• University of North Carlolina-Chapel Hill — Chapel Hill, 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
• Penn State MS Hershey Med Ctr — Hershey, Pennsylvania, United States
• St Christopher Hosp for Child — Philadelphia, Pennsylvania, United States
• Medical University Of SC — Charleston, South Carolina, United States
• Vanderbilt Hemostasis Thrombosis Clinic — Nashville, Tennessee, United States
• Univ of Utah Primary Children's Hospital — Salt Lake City, Utah, United States
• University of Virginia Children's Hospital — Charlottesville, Virginia, United States
• Children's Hsptl Of The Kings — Norfolk, Virginia, United States
• Beni Messous Hospital Issaad Hassani — Algiers, Algeria
• University Hospital Saadna Abdenour of Setif — Sétif, Algeria
• Miller Children's Hospital Long Beach — Long Beach, California, United States

Full record on ClinicalTrials.gov

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