Trial Condition(s):

Hemophilia A

Joint status in subjects with severe hemophilia A in relation to different treatment regimens

Bayer Identifier:

12948

ClinicalTrials.gov Identifier:

NCT00927667

EudraCT Number:

2009-010147-14

Terminated/Withdrawn

Trial Purpose

The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.

Inclusion Criteria
- Males aged 12 - 35 years  
 - Severe hemophilia A ( < 1 %  FVIII:C) 
 - No history of Factor VIII inhibitory antibody 
 - For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant  interruption and continuing until the present.  
 - Complete documentation of joints bleeds and their locations prior to start of prophylaxis,  
 - Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records. 
 - For the on-demand subjects > 12 bleeds/year in the  last 5 years. 
 - Written informed consent by subject and parent/legal representative, if < 18 years
Exclusion Criteria
- Individuals with other coagulopathies (e.g., von Willebrand disease) 
 - HIV seropositive subjects 
 - Individuals for whom the most clinically severe joint  is not one of the 4 index joints (ankle, knee)  
 - HCV seropositive individuals who underwent interferon therapy during the last 12 months 
 - Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
  - Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation  period
 - Joint replacement 
 - For the on-demand treatment group, any period greater than 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the  prevention of bleeding

Trial Summary

Enrollment Goal
156
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
No Drug
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Kurpfalzkrankenhaus Heidelberg gGmbH

Heidelberg, Germany, 69123

Status
Completed
 
Locations

Praxis für Innere Medizin u. Gefäßkrankheiten HBE

Magdeburg, Germany, 39112

Status
Completed
 
Locations

Kent & Canterbury Hospital

Canterbury, United Kingdom, CT1 3NG

Status
Terminated
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Hippokrateion University General Hospital of Athens

Athens, Greece, 115 27

Status
Completed
 
Locations

Praxis Hr. Dr. H. Pollmann

Münster, Germany, 48143

Status
Completed
 
Locations

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

Azienda Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Status
Completed
 
Locations

Skånes Universitetssjukhus Malmö

Malmö, Sweden, 205 02

Status
Completed
 
Locations

Laiko General Hospital of Athens

Athens, Greece, 115 27

Status
Completed
 

Trial Design