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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (18 locations)

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