Status:
COMPLETED
Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01205724
Start Date
September 1 2010
End Date
April 1 2011
Last Update
February 10 2017
Active Locations (18)
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1
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
2
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40536
3
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21287
4
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104