Trials / Completed
CompletedNCT00950170
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
AN OPEN-LABEL STUDY OF THE SAFETY AND EFFICACY OF REFACTO AF IN PREVIOUSLY UNTREATED PATIENTS IN USUAL CARE SETTINGS
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.
Detailed description
Regulatory Commitment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Laboratory Tests | Blood draws to determine the level of factor VIII activity before and after dosing at appropriate visits, and blood draws to determine levels of factor VIII inhibitor (antibody to factor VIII). |
Timeline
- Start date
- 2010-02-10
- Primary completion
- 2016-11-24
- Completion
- 2016-11-24
- First posted
- 2009-07-31
- Last updated
- 2019-07-19
- Results posted
- 2019-07-19
Locations
11 sites across 7 countries: France, Germany, Italy, Netherlands, Spain, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT00950170. Inclusion in this directory is not an endorsement.