do_not_disturb_altRecruitment Complete

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
  • - Male and female hemophilia A patients.
    - Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.

  • - 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
November 2016 - September 2025
Phase
N/A
Could I Receive a placebo
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Japan

Primary Outcome

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

Secondary Outcome

  • Number of annual bleeds
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    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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