Brief Title
2-cohort Study of Adult Patients With Severe Hemophilia A in Greece
Official Title
Prospective, Observational, 2-cohort Study of Adult Patients With Severe Hemophilia A in Greece. Cost,Clinical Outcomes and Quality of Life Comparison Between on Demand and Secondary Prophylaxis Treatment Strategies
Brief Summary
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.
Detailed Description
The primary therapy for hemophilia is coagulation factor replacement, given either episodically on demand (OD) for the treatment of acute bleeds or prophylactically to prevent them. The last years there has been an interest to study the comparative effectiveness of OD vs. SP (Secondary Prophylaxis) treatment strategies so as to create an evidence based platform to guide both clinical decision making and quantify the economic aspects of each treatment alternative. In Greece relevant information is lacking, thus it is imperative to study how patients on different treatment strategies are managed in a real-life setting in Greece, including the main factors associated with increased health care utilization, clinical success and patient well being.
Study Type
Observational
Primary Outcome
Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategy
Secondary Outcome
Mean cost per joint bleed episodes for overall patients
Condition
Hemophilia A
Intervention
Survey
Study Arms / Comparison Groups
Cohort 1
Description: Adult patients with severe Hemophilia A.(25 patients on Secondary Prophylaxis treatment)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
72
Start Date
January 13, 2015
Completion Date
February 28, 2018
Primary Completion Date
May 28, 2017
Eligibility Criteria
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.
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT02319070
Organization ID
17493
Secondary IDs
KG1411GR
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
June 2018