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

February 16, 2013 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69123
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Münster, Nordrhein-Westfalen, Germany, 48143
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
  • Greece
      • Athens, Greece, 115 27
  • Italy
      • Milano, Italy, 20122
      • Padova, Italy, 35121
      • Parma, Italy, 43100
      • Roma, Italy, 00161
  • Spain
      • A Coruña, Spain, 15006
      • Valencia, Spain, 46026
  • Sweden
      • Malmö, Sweden, 205 02
      • Stockholm, Sweden, 171 76
  • United Kingdom
      • London, United Kingdom, NW3 2QG
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Procedure: No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Procedure: No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Procedure: No Drug
Patients have received on-demand therapy
Experimental: Arm 2
Procedure: No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Procedure: No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Procedure: No Drug
Patients have received on-demand therapy
Experimental: Arm 3
Procedure: No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Procedure: No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Procedure: No Drug
Patients have received on-demand therapy
Experimental: Arm 4
Procedure: No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Procedure: No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Procedure: No Drug
Patients have received on-demand therapy
Experimental: Arm 5
Procedure: No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Procedure: No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Procedure: No Drug
Patients have received on-demand therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum ankle MRI score
Time Frame: no timeframe (single visit, "snapshot" of the actual joint status)
no timeframe (single visit, "snapshot" of the actual joint status)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 16, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12948
  • 2009-010147-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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