Trials / Completed
CompletedNCT02137850
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 0 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | turoctocog alfa pegol | For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis |
Timeline
- Start date
- 2014-06-26
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
- First posted
- 2014-05-14
- Last updated
- 2025-12-23
- Results posted
- 2024-10-31
Locations
96 sites across 23 countries: United States, Algeria, Argentina, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Mexico, Portugal, Puerto Rico, Romania, Serbia, Spain, Taiwan, Thailand, Ukraine
Source: ClinicalTrials.gov record NCT02137850. Inclusion in this directory is not an endorsement.