3 results
1.3. Study Design Rationale The ATLAS-INH trial (ALN-AT3SC-003) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with haemophilia A or B with inhibitory…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
We estimate that the anthracycline and cyclophosphamide dose could be significantly (>=15%) increased in at least 15% of ACC-treated patients. Therefore, in order to diminish the risk of under-dosing ACC, we aim to develop a neutrophil-guided…