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

EU CT Number:

Not Available

Terminated/Withdrawn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
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Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

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Kurpfalzkrankenhaus Heidelberg gGmbH

Heidelberg, Germany, 69123

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Praxis für Innere Medizin u. Gefäßkrankheiten HBE

Magdeburg, Germany, 39112

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Kent & Canterbury Hospital

Canterbury, United Kingdom, CT1 3NG

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Royal Free Hospital

London, United Kingdom, NW3 2QG

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A.O.U. di Parma

Parma, Italy, 43100

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Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

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Hippokrateion University General Hospital of Athens

Athens, Greece, 115 27

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Praxis Hr. Dr. H. Pollmann

Münster, Germany, 48143

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IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

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Azienda Policlinico Umberto I

Roma, Italy, 00161

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A.O. di Padova

Padova, Italy, 35128

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Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

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Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

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Skånes Universitetssjukhus Malmö

Malmö, Sweden, 205 02

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Laiko General Hospital of Athens

Athens, Greece, 115 27

Trial Design