A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe 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 safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

Key facts

Study ID

NCT01731600

Run by

Novo Nordisk A/S

People needed

68

Starts

2013-02-20

Expected to finish

2018-09-28

Last updated by the study team

2020-11-23

Who can join

Age: any, up to 11. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients with severe congenital haemophilia A (FVIII activity level below 1%)
• Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII products for patients aged 6-11 years and above 50 ED to FVIII products for patients aged 0-5 years

You may not qualify if…

• Any history of FVIII inhibitors

Where it is running

• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Boise, Idaho, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — New Orleans, Louisiana, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — New Hyde Park, New York, United States
• Novo Nordisk Investigational Site — Charlotte, North Carolina, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Charleston, South Carolina, United States
• Novo Nordisk Investigational Site — Nashville, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Charlottesville, Virginia, United States
• Novo Nordisk Investigational Site — Spokane, Washington, United States
• Novo Nordisk Investigational Site — Rio de Janeiro, Brazil
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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