2-cohort Study of Adult Patients With Severe Hemophilia A in Greece

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

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-13

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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.

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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Cohort 1

Adult patients with severe Hemophilia A.(25 patients on Secondary Prophylaxis treatment)

Survey

Intervention Type OTHER

Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine

Cohort 2

Adult patients with severe Hemophilia A.(50 patients on On Demand treatment)

Survey

Intervention Type OTHER

Recombinant antihemophilic factor VIII (FVIII) On Demand treatment scheduled according to daily routine

Interventions

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Survey

Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine

Intervention Type OTHER

Survey

Recombinant antihemophilic factor VIII (FVIII) On Demand treatment scheduled according to daily routine

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No