Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

Key facts

Study ID

NCT00840086

Run by

Novo Nordisk A/S

People needed

150

Starts

2009-04-01

Expected to finish

2011-09-01

Last updated by the study team

2017-03-17

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
• Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
• No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
• No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

You may not qualify if…

• Congenital or acquired coagulation disorders other than haemophilia A
• Creatinine levels 50% above normal level (as defined by central laboratory range)
• Known or suspected allergy to trial product (N8) or related products

Where it is running

• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Newark, New Jersey, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Providence, Rhode Island, United States
• Novo Nordisk Investigational Site — Memphis, Tennessee, United States
• Novo Nordisk Investigational Site — Nashville, Tennessee, United States
• Novo Nordisk Investigational Site — Fort Worth, Texas, United States
• Novo Nordisk Investigational Site — Spokane, Washington, United States
• Novo Nordisk Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novo Nordisk Investigational Site — Split, Croatia
• Novo Nordisk Investigational Site — Zagreb, Croatia
• Novo Nordisk Investigational Site — Copenhagen, Denmark
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Bonn, Germany
• Novo Nordisk Investigational Site — Giessen, Germany
• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.