Trials / Completed
CompletedNCT01436825
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 69 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile. The study takes place during a single visit, at the time of patient enrollment in the study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days . |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2014-06-01
- Completion
- 2015-07-01
- First posted
- 2011-09-20
- Last updated
- 2015-08-10
Locations
2 sites across 2 countries: France, Italy
Source: ClinicalTrials.gov record NCT01436825. Inclusion in this directory is not an endorsement.