Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Bayer

Status and phase: Completed; Phase 4

Conditions: Hemophilia A

Treatments: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810666

2014-001362-10 (EudraCT Number)

16287

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Recombinant Factor VIII

Experimental group

Treatment:

Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)