Terminated/Withdrawn

Hemophilia A

Bayer Identifier:

12948

ClinicalTrials.gov Identifier:

NCT00927667

EudraCT Number:

2009-010147-14

EU CT Number:

Not Available

Joint status in subjects with severe hemophilia A in relation to different treatment regimens

Trial 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.

Key Participants Requirements

Sex

Male

Age

12 - 35 Years

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

Trial summary

Enrollment Goal

156

Trial Dates

June 2009 - December 2010

Phase

Phase 4

Could I Receive a placebo

Products

No Drug

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Medizinische Einrichtungen der Universität Bonn	Bonn, 53105, Germany
Completed	Kurpfalzkrankenhaus Heidelberg gGmbH	Heidelberg, 69123, Germany
Completed	Praxis für Innere Medizin u. Gefäßkrankheiten HBE	Magdeburg, 39112, Germany
Terminated	Kent & Canterbury Hospital	Canterbury, CT1 3NG, United Kingdom
Completed	Royal Free Hospital	London, NW3 2QG, United Kingdom
Completed	A.O.U. di Parma	Parma, 43100, Italy
Completed	Karolinska Universitetssjukhuset i Solna	Stockholm, 171 76, Sweden
Completed	Hippokrateion University General Hospital of Athens	Athens, 115 27, Greece
Completed	Praxis Hr. Dr. H. Pollmann	Münster, 48143, Germany
Completed	IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milano, 20122, Italy
Completed	Azienda Policlinico Umberto I	Roma, 00161, Italy
Completed	A.O. di Padova	Padova, 35128, Italy
Completed	Hospital Universitari i Politècnic La Fe	Valencia, 46026, Spain
Completed	Complejo Hospitalario Universitario A Coruña	A Coruña, 15006, Spain
Completed	Skånes Universitetssjukhus Malmö	Malmö, 205 02, Sweden
Completed	Laiko General Hospital of Athens	Athens, 115 27, Greece

Primary Outcome

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

Secondary Outcome

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

Trial design

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

Trial Type

Interventional

Intervention Type

Procedure/Surgery

Trial Purpose

Diagnostic

Allocation

Non-randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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