Trials / Completed
CompletedNCT01493778
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 0 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | turoctocog alfa | Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person. |
Timeline
- Start date
- 2012-09-17
- Primary completion
- 2017-08-16
- Completion
- 2018-12-05
- First posted
- 2011-12-16
- Last updated
- 2020-11-30
- Results posted
- 2018-10-30
Locations
69 sites across 18 countries: United States, Algeria, Austria, Brazil, China, Denmark, Greece, Hong Kong, Hungary, Japan, Lithuania, Poland, Portugal, Puerto Rico, Russia, Serbia, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01493778. Inclusion in this directory is not an endorsement.