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

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

No Drug

About this trial

This is an interventional diagnostic trial for Hemophilia A focused on measuring Hemophilia A, Joint Status, Bleeds, Magnetic Resonce Imaging

Eligibility Criteria

12 Years - 35 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Outcomes

Primary Outcome Measures

Maximum ankle MRI score

Secondary Outcome Measures

Total MRI score of the maximum index joint

Number of bleeds in each index joint over previous 5 years

Number of total joint bleeds and their locations over previous 5 years

Physical joint score (Gilbert Score)

Full Information

NCT ID

NCT00927667

First Posted

June 23, 2009

Last Updated

February 16, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00927667

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

Keywords

Hemophilia A, Joint Status, Bleeds, Magnetic Resonce Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Experimental

Arm Title

Arm 4

Arm Type

Experimental

Arm Title

Arm 5

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

No Drug

Intervention Description

Patients have received primary FVIII prophylaxis (started < 2 years of age)

Intervention Type

Procedure

Intervention Name(s)

No Drug

Intervention Description

Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)

Intervention Type

Procedure

Intervention Name(s)

No Drug

Intervention Description

Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)

Intervention Type

Procedure

Intervention Name(s)

No Drug

Intervention Description

Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)

Intervention Type

Procedure

Intervention Name(s)

No Drug

Intervention Description

Patients have received on-demand therapy

Primary Outcome Measure Information:

Title

Maximum ankle MRI score

Time Frame

no timeframe (single visit, "snapshot" of the actual joint status)

Secondary Outcome Measure Information:

Title

Total MRI score of the maximum index joint

Time Frame

no timeframe (single visit, "snapshot" of the actual joint status)

Title

Number of bleeds in each index joint over previous 5 years

Time Frame

no timeframe (medical history status)

Title

Number of total joint bleeds and their locations over previous 5 years

Time Frame

no timeframe (medical history status)

Title

Physical joint score (Gilbert Score)

Time Frame

no timeframe (single visit, "snapshot" of the actual joint status)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69123

Country

Germany

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53105

Country

Germany

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48143

Country

Germany

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39112

Country

Germany

City

Athens

ZIP/Postal Code

115 27

Country

Greece

City

Milano

ZIP/Postal Code

20122

Country

Italy

City

Padova

ZIP/Postal Code

35121

Country

Italy

City

Parma

ZIP/Postal Code

43100

Country

Italy

City

Roma

ZIP/Postal Code

00161

Country

Italy

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

City

Valencia

ZIP/Postal Code

46026

Country

Spain

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

City

Canterbury

State/Province

Kent

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

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

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