2 results
Approved WMORecruiting
The primary aim of the trial is to demonstrate the non-inferiority of CSL222 (formerly AMT-061) (2 × 1013 gc/kg) during the 52 weeks following establishment of stable factor IX expression (months 6 to 18) post-treatment (CSL222 (formerly AMT-061))…
Approved WMORecruiting
Primary objectives:Safety:To demonstrate the safety of the investigational device in 10 subjects at 3 months post-surgery.Safety cohort data will be pooled with the performance cohort data, to measure the performance and safety of the…