stop_circleTerminated/Withdrawn

Hemophilia A

Bayer Identifier:

12948

ClinicalTrials.gov Identifier:

NCT00927667

EudraCT Number:

2009-010147-14

EU CT Number:

Not Available
Joint status in subjects with severe hemophilia A in relation to different treatment regimens

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.

Key Participants Requirements

Sex

Male

Age

12 - 35 Years

  • - 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

Trial summary

Enrollment Goal
156
Trial Dates
June 2009 - December 2010
Phase
Phase 4
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Completed
Kurpfalzkrankenhaus Heidelberg gGmbHHeidelberg, 69123, Germany
Completed
Praxis für Innere Medizin u. Gefäßkrankheiten HBEMagdeburg, 39112, Germany
Terminated
Kent & Canterbury HospitalCanterbury, CT1 3NG, United Kingdom
Completed
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Completed
A.O.U. di ParmaParma, 43100, Italy
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Hippokrateion University General Hospital of AthensAthens, 115 27, Greece
Completed
Praxis Hr. Dr. H. PollmannMünster, 48143, Germany
Completed
IRCCS Fondazione Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
Azienda Policlinico Umberto IRoma, 00161, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
Hospital Universitari i Politècnic La FeValencia, 46026, Spain
Completed
Complejo Hospitalario Universitario A CoruñaA Coruña, 15006, Spain
Completed
Skånes Universitetssjukhus MalmöMalmö, 205 02, Sweden
Completed
Laiko General Hospital of AthensAthens, 115 27, Greece

Primary Outcome

  • Maximum ankle MRI score
    date_rangeTime Frame:
    no timeframe (single visit, "snapshot" of the actual joint status)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Total MRI score of the maximum index joint
    date_rangeTime Frame:
    no timeframe (single visit, "snapshot" of the actual joint status)
    enhanced_encryption
    Safety Issue:
    no
  • Number of bleeds in each index joint over previous 5 years
    date_rangeTime Frame:
    no timeframe (medical history status)
    enhanced_encryption
    Safety Issue:
    no
  • Number of total joint bleeds and their locations over previous 5 years
    date_rangeTime Frame:
    no timeframe (medical history status)
    enhanced_encryption
    Safety Issue:
    no
  • Physical joint score (Gilbert Score)
    date_rangeTime Frame:
    no timeframe (single visit, "snapshot" of the actual joint status)
    enhanced_encryption
    Safety Issue:
    no

Trial design

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.