A Multi-National Trial Evaluating Safety and Efficacy Including Pharmacokinetics, of NNC 0129-0000-1003 when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia (Protocol No. NN7008-3859)

Service: Trial Number:
064-12
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes
Age Range:
7 years & up

The purpose of this research trial is to investigate the efficacy and safety of a new Factor VIII product called N8-GP for patients with Hemophilia A, factor VIII deficiency. The study consists of two treatment options. One option is a preventive treatment plan in which N8-GP is given in a vein every 4th day to prevent bleeding episodes. The second treatment option is to give the intravenous infusion of N8-GP as needed for bleeding episodes requiring treatment. A total of approximately 115 patients are expected to complete this study worldwide from approximately 75 hemophilia centers.

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