do_not_disturb_altRecruitment Complete
Hemophilia A
Bayer Identifier:
18706
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Drug Use Investigation of Kovaltry in hemophilia A patients
Trial purpose
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
231Trial Dates
November 2016 - September 2025Phase
N/ACould I Receive a placebo
NoProducts
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many Locations, Japan |
Primary Outcome
- Number of participants with adverse events as measure of safety and tolerabilitydate_rangeTime Frame:Up to 2 yearsenhanced_encryptionYesSafety Issue:
- Number of participants with serious adverse events as measure of safety and tolerabilitydate_rangeTime Frame:Up to 2 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Number of annual bleedsdate_rangeTime Frame:Up to 2 yearsenhanced_encryptionNoSafety Issue:
- Efficacy of controlling of bleedsThe efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.date_rangeTime Frame:Up to 2 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A