Trials / Completed
CompletedNCT00866606
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Benefix | BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion. |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2009-03-20
- Last updated
- 2011-04-05
- Results posted
- 2011-01-04
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT00866606. Inclusion in this directory is not an endorsement.