Trial Condition(s):

Blood Coagulation Disorders, Hemophilia A

Trial to Evaluate the Efficacy and Safety of a new full length recombinant human FVIII for Hemophilia A (Leopold I)

Bayer Identifier:

12954

ClinicalTrials.gov Identifier:

NCT01029340

EudraCT Number:

2009-012149-43

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
74
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Oxford, United Kingdom, OX3 7LJ

Status
Terminated
 
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Investigative Site

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
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Investigative Site

Sacramento, United States, 95817

Status
Completed
 
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Investigative Site

Krakow, Poland, 31-501

Status
Completed
 
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Investigative Site

A Coruña, Spain, 15006

Status
Completed
 
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Investigative Site

Valencia, Spain, 46026

Status
Completed
 
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Investigative Site

Göteborg, Sweden, 413 45

Status
Terminated
 
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Investigative Site

Malmö, Sweden, 205 02

Status
Terminated
 
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Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Terminated
 
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Investigative Site

Parktown, South Africa, 2132

Status
Completed
 
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Investigative Site

Wien, Austria, 1090

Status
Terminated
 
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Investigative Site

Jakarta, Indonesia, 10430

Status
Terminated
 
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Bangalore, India, 34

Status
Terminated
 
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Pune, India, 411005

Status
Terminated
 
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Tampa, United States, 33607

Status
Completed
 
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Boston, United States, 02115

Status
Completed
 
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Cleveland, United States, 44106-2602

Status
Completed
 
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Orange, United States, 92868

Status
Terminated
 
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Warszawa, Poland, 02-776

Status
Completed
 
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Barcelona, Spain, 08035

Status
Completed
 
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Santander, Spain, 39008

Status
Terminated
 
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Jaén, Spain, 23007

Status
Terminated
 
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DK-Aarhus N, Denmark, 8200

Status
Completed
 
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Oslo, Norway, 0027

Status
Terminated
 
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Pretoria, South Africa, 0001

Status
Completed
 
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Ramat Gan, Israel, 5262000

Status
Completed
 
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Mumbai, India, 400012

Status
Terminated
 
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Changhua, Taiwan, China, 500

Status
Terminated
 
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Hongkong, Hong Kong, China

Status
Completed
 
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Bangkok, Thailand, 10400

Status
Terminated
 
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Karachi, Pakistan, 75300

Status
Terminated
 
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Taipei, Taiwan, China, 11217

Status
Terminated
 
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Investigative Site

Taipei, Taiwan, China, 10016

Status
Terminated
 
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Investigative Site

Bangkok, Thailand, 10330

Status
Terminated
 
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Investigative Site

Bonn, Germany, 53127

Status
Completed
 
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Mainz, Germany, 55131

Status
Terminated
 
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Frankfurt, Germany, 60596

Status
Terminated
 
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Magdeburg, Germany, 39112

Status
Terminated
 
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Investigative Site

Dundee, United Kingdom, DD1 9SY

Status
Terminated
 
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East Lansing, United States, 48823

Status
Terminated
 
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Investigative Site

Kansas City, United States, 64108-9898

Status
Completed
 
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Milano, Italy, 20122

Status
Completed
 
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Investigative Site

Catanzaro, Italy, 88100

Status
Completed
 
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Vicenza, Italy, 36100

Status
Completed
 
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Napoli, Italy, 80131

Status
Completed
 
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Napoli, Italy, 80144

Status
Terminated
 
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Roma, Italy, 00168

Status
Terminated
 
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Oviedo, Spain, 33006

Status
Completed
 
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Investigative Site

Bahia Blanca, Argentina, B8001HXM

Status
Terminated
 
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Rosario, Argentina, S2000CKF

Status
Terminated
 
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Investigative Site

Graz, Austria, 8036

Status
Terminated
 
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Investigative Site

Izmir, Turkey, 35-100

Status
Completed
 
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Investigative Site

Adana, Turkey, 01330

Status
Completed
 
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Investigative Site

Antalya, Turkey, 07059

Status
Completed
 
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Investigative Site

Zagreb, Croatia, 10000

Status
Terminated
 
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Investigative Site

Nis, Serbia, 18000

Status
Terminated
 
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Investigative Site

Belgrade, Serbia, 11000

Status
Terminated
 
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Investigative Site

Novi Sad, Serbia, 21000

Status
Terminated
 
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Investigative Site

Beograd, Serbia, 11000

Status
Terminated
 
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Investigative Site

London, United Kingdom, SE1 7EH

Status
Terminated
 
Locations

Investigative Site

Homburg, Germany, 66421

Status
Terminated
 

Trial Design