A Phase 2b, Single-Arm, Open-Label, Multicenter Study of the Safety of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A
Hoffmann-La Roche
Summary
This study will assess the safety and tolerability of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Signed Informed Consent Form (ICF) * ≥18 years of age at the time of signing the ICF * Male sex assigned at birth * Severe or moderately severe hemophilia A, defined as endogenous FVIII:C activity levels ≤3%, as documented (historically or during the Screening Period) by a certified laboratory and where the FVIII:C level is measured more than 96 hours after the prior dose of an extended half-life FVIII replacement product or more than 72 hours after the prior dose of a standard half-life FVIII replacement product * Have documented treatment for a minimum of 6 months prio…
Interventions
- DrugSPK-8011QQ
Participants will receive IV SPK-8011QQ
Locations (2)
- Center for Inherited Blood DisordersOrange, California
- Kaiser PermanenteVallejo, California