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



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 65
Updated:4/21/2016
Start Date:December 2009
End Date:March 2013

Use our guide to learn which trials are right for you!

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

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)


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
We found this trial at
8
sites
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials