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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00927667
First received: June 23, 2009
Last updated: February 16, 2013
Last verified: February 2013
  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.


Condition Intervention Phase
Hemophilia A
Procedure: No Drug
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Maximum ankle MRI score [ Time Frame: no timeframe (single visit, "snapshot" of the actual joint status) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total MRI score of the maximum index joint [ Time Frame: no timeframe (single visit, "snapshot" of the actual joint status) ] [ Designated as safety issue: No ]
  • Number of bleeds in each index joint over previous 5 years [ Time Frame: no timeframe (medical history status) ] [ Designated as safety issue: No ]
  • Number of total joint bleeds and their locations over previous 5 years [ Time Frame: no timeframe (medical history status) ] [ Designated as safety issue: No ]
  • Physical joint score (Gilbert Score) [ Time Frame: no timeframe (single visit, "snapshot" of the actual joint status) ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Procedure: No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
Experimental: Arm 2 Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Experimental: Arm 3 Procedure: No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Experimental: Arm 4 Procedure: No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Experimental: Arm 5 Procedure: No Drug
Patients have received on-demand therapy

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927667

Locations
Germany
Heidelberg, Baden-Württemberg, Germany, 69123
Bonn, Nordrhein-Westfalen, Germany, 53105
Münster, Nordrhein-Westfalen, Germany, 48143
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
Canterbury, Kent, United Kingdom, CT1 3NG
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00927667     History of Changes
Other Study ID Numbers: 12948, 2009-010147-14
Study First Received: June 23, 2009
Last Updated: February 16, 2013
Health Authority: Germany:Paul-Ehrlich-Institut, Langen

Keywords provided by Bayer:
Hemophilia A
Joint Status
Bleeds
Magnetic Resonce Imaging

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014