NCT01731600

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 0 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa pegol	Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.

Timeline

• Start date: 2013-02-20
• Primary completion: 2014-09-15
• Completion: 2018-09-28
• First posted: 2012-11-22
• Last updated: 2020-11-23
• Results posted: 2019-10-30

Locations

51 sites across 16 countries: United States, Brazil, Canada, France, Greece, Israel, Italy, Japan, Lithuania, Malaysia, Portugal, Puerto Rico, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom