Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients

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

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-04

Study Completion Date

2019-05-23

Brief Summary

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The project is an observational, multi-central, prospective, non-interventional and open-label data collection study on secondary prophylaxis with recombinant FVIII products in adolescents and adults with severe hemophilia A (FVIII \< 1%).

It will be a controlled observation of patients on secondary prophylaxis versus on-demand treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to prophylaxis and on-demand treatment.

The patient enrollment period will be 2 years with a follow-up (observation period) of 2 years for each patient. Based on the primary effectiveness parameters (joint bleeds and overall bleeds per year) an observation period of 2 years is considered sufficient although it has to be admitted that it is rather short to assess the progression of orthopedic status. Previously treated prophylaxis patients with at least 50 exposure days and patients with continuing prophylaxis treatment will be included.

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Detailed Description

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Conditions

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Hemophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Recombinant Factor VIII (Kogenate, BAY14-2222)

Intervention Type OTHER

All dosage, frequency and duration for drugs will be under the decision of the treating physician.

Interventions

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Recombinant Factor VIII (Kogenate, BAY14-2222)

All dosage, frequency and duration for drugs will be under the decision of the treating physician.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Severe hemophilia A (FVIII\<1%) diagnosis
* Prior treatment or ongoing treatment with on-demand or prophylaxis regimens according to Turkish guidelines and requirements
* Previously treated patients with at least \>50 exposure days
* Written informed consent signed by patient/legal representative

Exclusion Criteria

* Currently on immune tolerance treatment
* Platelet count \< 75,000/mm3
* Participation in another study
* Existence of inhibitors in the past and in the last currently available blood sample prior to study start (Bethesda titer \< 0.6 BU/ml)
* Existence of inhibitor history in family members who also are diagnosed with hemophilia A
* Having been on primary prophylaxis as defined in the introduction
* Participation in another study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No