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

All

Age

NaN - N/A (No Limit)

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

Phase IV

Could I Receive a placebo

Products

Octocog alfa, BAY 2350145

Accepts Healthy Volunteer

Primary Outcome

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

Secondary Outcome

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
Number of annual bleeds
Time Frame:
Up to 2 years

Trial design

Special Drug Investigation of Kovaltry in hemophilia A patients

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

Open Label

Assignment

N/A

Trial Arms

N/A