Brief Title
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
Official Title
A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)
Brief Summary
The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Annualized Number of All Bleeds
Secondary Outcome
Annualized Number of All Bleeds During CS/EP Period
Condition
Hemophilia A
Intervention
rFVIII (BAY81-8973) on demand
Study Arms / Comparison Groups
Arm 1: rFVIII on demand first CS/EP then CS/ADJ
Description: Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
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
Biological
Estimated Enrollment
80
Start Date
January 2011
Completion Date
December 2012
Primary Completion Date
December 2012
Eligibility Criteria
Inclusion Criteria: - Male, aged 12 to 65 years - Severe hemophilia A - History of more than 150 exposure days (ED) with clotting factor concentrates - Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years - No current Factor VIII inhibitor or history of inhibitor - Willing to use electronic patient diary Exclusion Criteria: - Presence of another bleeding disease that is different from hemophilia A - Thrombocytopenia - Abnormal renal function - Presence of active liver disease - Known hypersensitivity to FVIII
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT01233258
Organization ID
14319
Secondary IDs
2009-012150-20
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
October 2016