Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

Completed

• Conditions: Hematologic Disease; Blood Coagulation Disorders
• Interventions: Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)

• Registration Number: NCT00782470
• Lead Sponsor: Bayer

Brief Summary

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

Inclusion Criteria

• Severe hemophilia A (<2%)
• For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
• For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
• For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
• Current treatment with rFVIII

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Exclusion Criteria

• Other known hematological / bleeding disorders other than hemophilia A
• Participating on another study that may have an impact on bleeding or the objectives of this study
• Known alcohol and drug abuse

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Recombinant Factor VIII (Kogenate, BAY 14-2222)	-
Group 3	Recombinant Factor VIII (Kogenate, BAY 14-2222)	-
Group 2	Recombinant Factor VIII (Kogenate, BAY 14-2222)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the frequency of all bleeds (spontaneous and trauma) during the study	End of Study

Secondary Outcome Measures

Name	Time	Method
To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy	End of Study
To evaluate the change from baseline in HRQoL (health-related quality of life)	End of Study
To evaluate the change from baseline in the Gilbert score	End of Study
To evaluate the number of target joint development	End of Study