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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00586521
Other study ID # 11859
Secondary ID 2005-002757-45
Status Completed
Phase Phase 4
First received December 21, 2007
Last updated October 27, 2014
Start date February 2006
Est. completion date March 2008

Study information

Verified date October 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Male
Age group 30 Years to 45 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Kogenate (BAY14-2222)
One group two treatment schedules, first on-demand then switch to prophylaxis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Joint Bleeds 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) No
Secondary Number of All Bleeds 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) No
Secondary Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score 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) No
Secondary Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire 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) No
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