KEYSTONE-1
Brief description of study
To evaluate the efficacy of SPK-8011
in preventing bleed episodes
compared with FVIII prophylaxis in
patients with hemophilia A without
FVIII inhibitors on routine FVIII
prophylaxis. To evaluate the efficacy of SPK-8011
in preventing bleed episodes
compared with FVIII prophylaxis in
patients with hemophilia A without
FVIII inhibitors on routine FVIII
prophylaxis.
In Cohort A:
Mean ABR for treated bleeds in Cohort A starting
from 28 days post-SPK-8011 infusion, relative to the
mean ABR for treated bleeds during the Lead-In
Period, at time of primary analysis To evaluate the efficacy of SPK-8011
in patients with hemophilia A without
FVIII inhibitors on routine FVIII
prophylaxis by assessing FVIII
activity following SPK-8011 infusion.
To describe the immunomodulation
received following SPK-8011
infusion.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: - 99 Years
-
Gender: All
TBD
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