Trials / Completed
CompletedNCT00749476
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.
Detailed description
The switch to BeneFIX has already been decided by the investigator. Patients will be followed up to 3 months after the switch.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Factor IX recovery |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2008-09-09
- Last updated
- 2011-06-08
- Results posted
- 2010-06-29
Locations
8 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00749476. Inclusion in this directory is not an endorsement.