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

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927667
• Other study ID #: 12948
• Secondary ID: 2009-010147-14
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2009
• Last updated: February 16, 2013
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:Paul-Ehrlich-Institut, Langen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 35 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Procedure:
• No Drug
Patients have received primary FVIII prophylaxis (started < 2 years of age)
• No Drug
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
• No Drug
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
• No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
• No Drug
Patients have received on-demand therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Greece,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum ankle MRI score		no timeframe (single visit, "snapshot" of the actual joint status)	No
Secondary	Total MRI score of the maximum index joint		no timeframe (single visit, "snapshot" of the actual joint status)	No
Secondary	Number of bleeds in each index joint over previous 5 years		no timeframe (medical history status)	No
Secondary	Number of total joint bleeds and their locations over previous 5 years		no timeframe (medical history status)	No
Secondary	Physical joint score (Gilbert Score)		no timeframe (single visit, "snapshot" of the actual joint status)	No

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