Trials / Completed
CompletedNCT01392547
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.
Detailed description
Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vatreptacog alfa (activated) | 1-3 doses per bleeding episode |
| DRUG | eptacog alfa (activated) | 1-3 doses per bleeding episode |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2011-07-12
- Last updated
- 2017-05-15
- Results posted
- 2013-12-06
Locations
32 sites across 19 countries: United States, Austria, Brazil, Croatia, Greece, Hungary, Italy, Japan, Malaysia, Poland, Puerto Rico, Romania, Russia, Serbia, South Africa, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01392547. Inclusion in this directory is not an endorsement.