Trial Condition(s):

Hemophilia A

Patient functioning and well-being, economic, and clinical impact of hemophilia A and its treatment (ECHO)

Bayer Identifier:

17285

ClinicalTrials.gov Identifier:

NCT02396862

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of the study is to improve the understanding of key patient reported outcomes such as quality of life as well as clinical outcomes in hemophilia A, in a global real world setting.

Inclusion Criteria
-  Age 16 or over.
 -  Have documentation of physician-confirmed diagnosis of moderate or severe Hemophilia A (severity defined as moderate = FVIII activity 1% to 5% and severe = FVIII activity ≤1%).
 -  Signed written informed consent provided by the patient or the patient’s parents for patients under the age of 18 (dependent of local regulations).
 -  Signed written assent is also required for patients under the age 18 years (dependent on local regulations).
 -  Plan to receive at least half of their Hemophilia care at the registry site. 
 - Willing and able to enter data as per the data collection schedule.
 - Currently receiving prophylactic or on demand treatment (including within last 6months for on demand).
 -  Expected life expectancy of at least 2 years.
Exclusion Criteria
-  Patients with Hemophilia B
 -  Patients with von Willebrand disease (vWD)
 -  Patients with other rare bleeding disorders      
 -  Unable to comply with the study protocol

Trial Summary

Enrollment Goal
272
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 
Locations

Investigative Site

Detroit, United States

Status
Active, not recruiting
 
Locations

Investigative Site

Many Locations, Spain

Status
Active, not recruiting
 
Locations

Investigative Site

Columbus, United States

Status
Active, not recruiting
 
Locations

Investigative Site

New Orleans, United States

Status
Active, not recruiting
 
Locations

Investigative Site

Aurora, United States

Status
Active, not recruiting
 
Locations

Investigative Site

Phoenix, United States

Status
Active, not recruiting
 
Locations

Investigative Site

Washington, United States

Status
Active, not recruiting
 
Locations

Investigative Site

Minneapolis, United States

Status
Active, not recruiting
 

Trial Design