Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-09

Study Completion Date

2018-03-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with moderate to severe Hemophilia A / Cohort 1

Patients aged over 16 years, with documented physician-confirmed diagnosis of moderate or severe Hemophilia A (severity defined as moderate = FVIII activity 1% to 5% and severe = FVIII activity ≤1%)

Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222)

Intervention Type DRUG

Recombinant and Human Factor VIII / Used on demand or prophylaxis of bleeds

Interventions

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Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222)

Recombinant and Human Factor VIII / Used on demand or prophylaxis of bleeds

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No