Trial Condition(s):
Joint status in subjects with severe hemophilia A in relation to different treatment regimens
12948
Not Available
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.
- 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
- 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
Locations | |
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Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurpfalzkrankenhaus Heidelberg gGmbH Heidelberg, Germany, 69123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis für Innere Medizin u. Gefäßkrankheiten HBE Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kent & Canterbury Hospital Canterbury, United Kingdom, CT1 3NG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Free Hospital London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Parma Parma, Italy, 43100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hippokrateion University General Hospital of Athens Athens, Greece, 115 27 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Pollmann Münster, Germany, 48143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Azienda Policlinico Umberto I Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario Universitario A Coruña A Coruña, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skånes Universitetssjukhus Malmö Malmö, Sweden, 205 02 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Laiko General Hospital of Athens Athens, Greece, 115 27 | Contact Us: E-mail: [email protected] Phone: Not Available |
A diagnostic interventional, controlled, cross-sectional evaluation of joint status using Magnetic Resonance Imaging in subjects with severe hemophilia A treated with primary prophylaxis, secondary prophylaxis, or on-demand therapy
Trial Type:
Interventional
Intervention Type:
Procedure/Surgery
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
5