Phase 4
Completed N=32
Russian Kogenate Pediatric Study
Source: ClinicalTrials.gov NCT00632814 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Feb 2011
Primary outcomePrimary: Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period — 72.7; 84.6; 75.0 Percentage of participants
Summary
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period |
72.7; 84.6; 75.0 | — |
| SECONDARY Number of Bleeds Per Participant During the 9-month Treatment Period |
3.0; 2.0; 1.5; 0; 0; 0 | — |
| SECONDARY Number of Participants With Bleeding Events During the 9-month Treatment Period |
3; 4; 4; 8; 9; 4 | — |
| SECONDARY Number of Participants With Joint Bleeds During the 9-month Treatment Period |
8; 9; 6; 3; 4; 2 | — |
| SECONDARY Number of Participants in Each Group at the End of the Study |
8; 14; 10 | — |
| SECONDARY Actual Monthly rFVIII-FS Consumption |
390.8; 422.3; 501.4 | — |
| SECONDARY Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment |
-1.4; -2.0; -1.8 | — |
| SECONDARY Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group) |
30.28; 39.07; 30.27 | — |
| SECONDARY Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment |
29.13; 28.43; 31.38 | — |
Eligibility Criteria
Inclusion Criteria
- Male
- Severe hemophilia A or moderate hemophilia A
- 1-12 years of age
- Requiring treatment with FVIII
Exclusion Criteria
- Current or prior inhibitor or familial antecedents of inhibitor
- Surgery required during the study (9 months)
- Positive for HIV
Data sourced from ClinicalTrials.gov (NCT00632814). 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. Informational only — not medical advice.