Trials / Completed
CompletedNCT01335061
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nonacog alfa | Period 1: During on-demand period, dosing at the discretion of investigator. |
| BIOLOGICAL | Nonacog alfa | Period 2: During the prophylaxis period, 100 IU/kg once weekly |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2011-04-13
- Last updated
- 2015-06-08
- Results posted
- 2015-05-04
Locations
17 sites across 9 countries: Bulgaria, Canada, Croatia, Malaysia, Mexico, Poland, Singapore, South Korea, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01335061. Inclusion in this directory is not an endorsement.