BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00586521
First received: December 21, 2007
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hematologic Disease
Hemophilia A
Drug: Kogenate (BAY14-2222)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Joint Bleeds [ Time Frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) ] [ Designated as safety issue: No ]
    Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6


Secondary Outcome Measures:
  • Number of All Bleeds [ Time Frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) ] [ Designated as safety issue: No ]
    Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)

  • 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) ] [ Designated as safety issue: No ]
    Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIII-FS (octocog-alfa), (Kogenate FS)
On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
Drug: Kogenate (BAY14-2222)
One group two treatment schedules, first on-demand then switch to prophylaxis

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586521

Locations
United States, Colorado
Aurora, Colorado, United States, 80045
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Houston, Texas, United States, 77030
France
Strasbourg, France, 67098
Italy
Firenze, Italy, 50134
Pavia, Italy, 27100
Roma, Italy, 00161
Spain
Sta. Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38009
Madrid, Spain, 28046
United Kingdom
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00586521     History of Changes
Other Study ID Numbers: 11859, 2005-002757-45
Study First Received: December 21, 2007
Results First Received: April 3, 2009
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Coagulation Disorders

Additional relevant MeSH terms:
Hematologic Diseases
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014