NCT01480180

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

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 A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa pegol	Administered i.v.

Timeline

• Start date: 2012-01-30
• Primary completion: 2018-12-10
• Completion: 2018-12-10
• First posted: 2011-11-28
• Last updated: 2020-11-23
• Results posted: 2020-04-20

Locations

93 sites across 24 countries: United States, Australia, Brazil, Bulgaria, Croatia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Puerto Rico, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom