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OpenTrials
Completed

NCT Number: NCT00782470

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

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.

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Key information

Conditions

Hematologic Disease Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

14 year–29 year

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Behavioral

Subjects electing to stay on the prophylactic treatment (prospective)

Primary outcomes

  1. To evaluate the frequency of all bleeds (spontaneous and trauma) during the study

    Time frame: End of Study

Secondary outcomes

  1. To evaluate the change from baseline in HRQoL (health-related quality of life)

    Time frame: End of Study

  2. To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy

    Time frame: End of Study

  3. To evaluate the change from baseline in the Gilbert score

    Time frame: End of Study

  4. To evaluate the number of target joint development

    Time frame: End of Study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and On-demand Treatment Regimen

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 31, 2008
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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