Phase 4
N=20
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Hematologic Disease · Hemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT00586521 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Nov 2009
Primary outcome: Primary: Number of Joint Bleeds — 18.5; 1.5 Number of joint bleeds — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Kogenate (BAY14-2222) (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Bayer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Joint Bleeds |
18.5; 1.5 | <0.001 sig |
| SECONDARY Number of All Bleeds |
23.7; 1.9 | <0.001 sig |
| SECONDARY Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score |
25.3; 19.8 | <0.001 sig |
| SECONDARY Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire |
73.4; 75.9 | 0.314 |
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.
Eligibility Criteria
Inclusion Criteria
- Severe hemophilia A ( 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
Data sourced from ClinicalTrials.gov (NCT00586521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.