Study Completed

Hemophilia A

Bayer Identifier:

18706

ClinicalTrials.gov Identifier:

NCT02941783

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

Both

Age

NaN - N/A

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

230

Trial Dates

November 2016 - September 2025

Phase

N/A

Could I Receive a placebo

Products

Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Recruiting	Many Locations	Many Locations, Japan

Primary Outcome

Number of participants with adverse events as measure of safety and tolerability
Time Frame:
Up to 2 years
Safety Issue:
Yes
Number of participants with serious adverse events as measure of safety and tolerability
Time Frame:
Up to 2 years
Safety Issue:
Yes

Secondary Outcome

Number of annual bleeds
Time Frame:
Up to 2 years
Safety Issue:
No
Efficacy of controlling of bleeds
The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.
Time Frame:
Up to 2 years
Safety Issue:
No

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

N/A

Additional Information

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