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NCT Number: NCT00586521

BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.

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Key information

Conditions

Hematologic Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

30 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Strasbourg, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe hemophilia A (< 1% FVIII)
  • 30-45 years of age
  • Previously treated subject (> 100 Exposure days to any FVIII)
  • On-demand therapy with any FVIII

Exclusion criteria

  • No history of inhibitor
  • No planned elective orthopedic surgery during the study duration (13 months)
  • No severe concomitant disease
  • No history of anaphylactic or other severe reaction to previous FVIII treatment

Treatment and study plan

Kogenate (BAY14-2222)

Drug

One group two treatment schedules, first on-demand then switch to prophylaxis

Primary outcomes

  1. Number of Joint Bleeds

    Time frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)

    Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6

Secondary outcomes

  1. Number of All Bleeds

    Time frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)

    Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)

  2. Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score

    Time frame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)

    Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage

  3. Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire

    Time frame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)

    Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 4, 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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