Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-01-31

Brief Summary

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Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recombinant Factor VIII

Group Type EXPERIMENTAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type BIOLOGICAL

Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male, aged 2-16yrs
* Severe hemophilia A (\<1% FVIII:C \[Blood Clotting Factor VIII:C\] )
* Minimum of at least 50 documented ED (exposure day) prior to enrolment
* No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
* Parents or legal guardians document, sign, and date informed consent

Exclusion Criteria

* Another bleeding disease that is different from hemophilia A
* Known hypersensitivity to the active substance, mouse or hamster protein
* Thrombocytopenia (platelet count \<100 000/mm3) based on previous medical records

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No