Trial Condition(s):
Hemophilia A
Drug Use Investigation of Kovaltry in hemophilia A patients
Bayer Identifier:
18706
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Recruitment Complete
Trial Purpose
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
Inclusion Criteria
- Male and female hemophilia A patients. - Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.
Exclusion Criteria
- Patients participating in an investigational program with interventions outside of routine clinical practice. - Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
Trial Summary
Enrollment Goal
231
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Japan | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation of Kovaltry in hemophilia A patients
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with adverse events as measure of safety and tolerabilityTimeframe: Up to 2 years
- Number of participants with serious adverse events as measure of safety and tolerabilityTimeframe: Up to 2 years
Secondary Outcome
- Number of annual bleedsTimeframe: Up to 2 years
- Efficacy of controlling of bleedsThe efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.Timeframe: Up to 2 years
Additional Information
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