check_circleStudy Completed
Haemophilia A
Bayer Identifier:
15453
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Validation study of a cOmputer Pharmacokinetic Tool to assIst in the follow up care of haeMophilia A patients
Trial purpose
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
The study takes place during a single visit, at the time of patient enrollment in the study
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
69Trial Dates
October 2011 - July 2015Phase
N/ACould I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, France | |
Completed | Many Locations, Italy |
Primary Outcome
- The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tooldate_rangeTime Frame:after 1 monthenhanced_encryptionNoSafety Issue:
- The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tooldate_rangeTime Frame:after 1 monthenhanced_encryptionNoSafety Issue:
- The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tooldate_rangeTime Frame:after 1 monthenhanced_encryptionNoSafety Issue:
Secondary Outcome
- The dosage of factor VIII calculated by OPTIMS calculatordate_rangeTime Frame:within 48 hours after enrollmentenhanced_encryptionNoSafety Issue:
- The practicality of the OPTIMS calculator by a physician's satisfaction questionnairedate_rangeTime Frame:within 48 hours after enrollmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A