BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

October 27, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
  • Italy
      • Firenze, Italy, 50134
      • Pavia, Italy, 27100
      • Roma, Italy, 00161
  • Spain
      • Madrid, Spain, 28046
    • Santa Cruz de Tenerife
      • Sta. Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38009
  • United Kingdom
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
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
Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
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.
Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11859 (DAIDS ES)
  • 2005-002757-45 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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