Trials / Completed
CompletedNCT02213250
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
An Open-label, Single Dose Pharmacokinetic Study Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BENEFIX | Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2014-08-11
- Last updated
- 2016-07-25
- Results posted
- 2016-07-25
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02213250. Inclusion in this directory is not an endorsement.