Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia B

In brief

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

Key facts

Study ID

NCT01467427

Run by

Novo Nordisk A/S

People needed

25

Starts

2012-05-16

Expected to finish

2023-11-17

Last updated by the study team

2025-12-23

Who can join

Age: any, up to 12. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records
• Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)
• Body weight above or equal to 10 kg
• History of at least 50 exposure days (EDs) to other FIX products
• The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures

You may not qualify if…

• Known history of FIX inhibitors
• Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)
• Congenital or acquired coagulation disorder other than haemophilia B
• Platelet count below 50,000/mcL at screening
• Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening
• Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening
• Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL
• Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids)
• Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Colorado Hemophilia & Thrombosis Center — Aurora, Colorado, United States
• Childrens National Medical Ctr — Washington D.C., District of Columbia, United States
• University of Miami Hospital & Clinics — Miami, Florida, United States
• Emory University_Atlanta_1 — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• University Of Iowa — Iowa City, Iowa, United States
• University Of Louisville_Louisville_0 — Louisville, Kentucky, United States
• Johns Hopkins University_Baltimore_3 — Baltimore, Maryland, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Hospitals And Clinics Of Minnesota — Minneapolis, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Univ of NE Med Center_Omaha — Omaha, Nebraska, United States
• Rutgers-Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Univ Hosp Cleveland Med Ctr — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Dayton Children Hemostati Ctr — Dayton, Ohio, United States
• Univ Oklahoma Sci Ctr OK City — Oklahoma City, Oklahoma, United States
• Children's Hosptl Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt Hemostasis Thrombosis Clinic — Nashville, Tennessee, United States
• Children's Medical Center_Dallas — Dallas, Texas, United States
• Texas Children's Hospital_Houston — Houston, Texas, United States
• Children's Hospital Los Angeles - Endocrinology — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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