Brief Title
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
Official Title
A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy
Brief Summary
The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Part A - Area Under the Drug Concentration-time Curve (AUC)
Secondary Outcome
Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII)
Condition
Blood Coagulation Disorders
Intervention
Recombinant Factor VIII (BAY81-8973)
Study Arms / Comparison Groups
Arm 1: Recombinant Factor VIII (BAY81-8973) then Kogenate FS
Description: Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
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
74
Start Date
December 2009
Completion Date
March 2013
Primary Completion Date
June 2012
Eligibility Criteria
Inclusion Criteria: - Male, aged 12 to 65 years - Severe hemophilia A defined as < 1% FVIII:C - >/= 150 days of previous treatment with FVIII in lifetime - Currently receiving on-demand or any type of prophylaxis treatment regimen with any FVIII product - No history of or current FVIII inhibitors Exclusion Criteria: - Presence of another bleeding disease that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B) - Low platelet count, abnormal kidney function, or liver disease - Received treatment with immune suppressing drugs within the last 3 months prior or requires treatment during the study. (Some drugs for hepatitis C, Human immunodeficiency virus (HIV), and steroids are allowed) - Receiving or has received other experimental drugs within 3 months prior to study entry - Allergy to Factor VIII or hamsters or mouse protein
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
NCT01029340
Organization ID
12954
Secondary IDs
2009-012149-43
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
October 2016