Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00927667

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
Hemophilia A	Procedure: No Drug

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia MRI Scans

U.S. FDA Resources

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 ]

Estimated Enrollment:	280
Study Start Date:	June 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Procedure: No Drug Patients have received primary FVIII prophylaxis (started < 2 years of age)
Arm 2: Experimental	Procedure: No Drug Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
Arm 3: Experimental	Procedure: No Drug Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
Arm 4: Experimental	Procedure: No Drug Patients have received secondary VIII prophylaxis (started 12 - 18 years of age)
Arm 5: Experimental	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

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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Germany, Baden-Württemberg
	Recruiting
Heidelberg, Baden-Württemberg, Germany, 69123
Germany, Nordrhein-Westfalen
	Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
	Not yet recruiting
Münster, Nordrhein-Westfalen, Germany, 48143
Germany, Sachsen-Anhalt
	Not yet recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39112
Greece, Attica
	Not yet recruiting
Athens, Attica, Greece, 11527
Greece, Attica / Greece
	Not yet recruiting
Athens, Attica / Greece, Greece, 115 27
Italy
	Not yet recruiting
Parma, Italy, 43100
	Not yet recruiting
Milano, Italy, 20122
	Not yet recruiting
Roma, Italy, 00155
	Not yet recruiting
Padova, Italy, 35128
Sweden
	Not yet recruiting
Malmö, Sweden, 205 02
	Not yet recruiting
Stockholm, Sweden, 171 76
United Kingdom, Greater London
	Not yet recruiting
London, Greater London, United Kingdom, NW3 2QG
United Kingdom, Kent
	Not yet recruiting
Canterbury, Kent, United Kingdom, CT1 3NG

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Head Clinical Pharmacology )
Study ID Numbers:	12948, EudraCT:2009-010147-14
Study First Received:	June 23, 2009
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00927667 History of Changes
Health Authority:	Germany:Paul-Ehrlich-Institut, Langen

Keywords provided by Bayer:

Hemophilia A
Joint Status
Bleeds
Magnetic Resonce Imaging

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Neoplasm Metastasis
Hemostatic Disorders

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on September 09, 2009