Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Haemophilia A

• Body Mass Index (BMI) below 35 kg/m2

• History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)

Exclusion Criteria:

• Any history of FVIII inhibitors

• Surgery planned to occur during the trial

• Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)

• Congenital or acquired coagulation disorders other than haemophilia A