Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

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

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

Secondary IDs

2009-012149-43

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

October 2016