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OpenTrials
Completed

NCT Number: NCT00927667

Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens

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.

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Key information

Age range

12 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Heidelberg, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Drug

Procedure

Patients have received primary FVIII prophylaxis (started < 2 years of age)

Primary outcomes

  1. Maximum ankle MRI score

    Time frame: no timeframe (single visit, "snapshot" of the actual joint status)

Secondary outcomes

  1. Total MRI score of the maximum index joint

    Time frame: no timeframe (single visit, "snapshot" of the actual joint status)

  2. Number of bleeds in each index joint over previous 5 years

    Time frame: no timeframe (medical history status)

  3. Number of total joint bleeds and their locations over previous 5 years

    Time frame: no timeframe (medical history status)

  4. Physical joint score (Gilbert Score)

    Time frame: no timeframe (single visit, "snapshot" of the actual joint status)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2009
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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