Trial Condition(s):

Hemophilia A

2-cohort study of adult patients with severe Hemophilia A in Greece (HAMLET)

Bayer Identifier:

17493

ClinicalTrials.gov Identifier:

NCT02319070

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study is a prospective, single center, observational, 2-cohort study of adult patients with severe Hemophilia A. There is no randomization procedure and all patients will be treated as per usual clinical practice. Patients will be followed up for 18 months after enrolment.

Inclusion Criteria
- Patients diagnosed with severe Hemophilia A.
 - Age ≥18 years old
 - Patients able to read and write
 - Patients receiving Factor VIII substitute therapy, either on-demand or as secondary prophylaxis.
 - Patients under the same therapeutic strategy (On Demand or Secondary Prophylaxis) for at least 6 months prior to enrolment.
Exclusion Criteria
- Patients that have developed inhibitors against factor VIII.
 - Patients participating in an investigational program with interventions outside of routine clinical practice.

Trial Summary

Enrollment Goal
72
Trial Dates
black-arrow
Phase
N/A
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, Greece

Status
Completed
 

Trial Design