Expired Study
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Chapel Hill, North Carolina 27599


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.


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


Study is Available At:


Original ID:

11859


NCT ID:

NCT00586521


Secondary ID:

2005-002757-45


Study Acronym:


Brief Title:

BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Male


Minimum Age:

30 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bayer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bayer Study Director
Study Director
Bayer

Study Dates

Start Date:February 2006
Completion Date:March 2008
Completion Type:Actual
Primary Completion Date:March 2008
Primary Completion Type:Actual
Verification Date:December 2012
Last Changed Date:December 6, 2012
First Received Date:December 21, 2007
First Results Date:April 3, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage
Outcome Type:Secondary Outcome
Measure:Number of All Bleeds
Time Frame:Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
Safety Issues:False
Description:Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)
Outcome Type:Primary Outcome
Measure:Number of Joint Bleeds
Time Frame:Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
Safety Issues:False
Description:Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6

Study Interventions

Intervention Type:Drug
Name:Kogenate (BAY14-2222)
Description:One group two treatment schedules, first on-demand then switch to prophylaxis
Arm Name:rFVIII-FS (octocog-alfa), (Kogenate FS)

Study Arms

Study Arm Type:Experimental
Arm Name:rFVIII-FS (octocog-alfa), (Kogenate FS)
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bayer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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