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

Phase 4

Completed

• Conditions: Hemophilia A
• Interventions: Procedure: No Drug

• Registration Number: NCT00927667
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-16
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 156

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	No Drug	-
Arm 2	No Drug	-
Arm 3	No Drug	-
Arm 4	No Drug	-
Arm 5	No Drug	-

Primary Outcome Measures

Name	Time	Method
Maximum ankle MRI score	no timeframe (single visit, "snapshot" of the actual joint status)

Secondary Outcome Measures

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