7 results
To demonstrate the safety and effectiveness of the Tryton Side Branch Stent* with main branch approved DES compared to side branch balloon angioplasty and main branch approved DES in the treatment of de novo native coronary artery bifurcation…
To assure the continued safety and effectiveness of the Tryton Side Branch Stent* with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from >=2.5 mm to <…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…
Primary Objective:- Achieving an event-free survival, which is not inferior to the ML-DS 2006 trial (87±3%)Secondary Objective(s):- Reduction of toxicity: severe adverse events (CTCAE v4.0 grade III or higher)- Evaluation of response- Identification…
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…
Primary objective:•To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML Secondary objectives:•To determine the safety and tolerability of this combination•To determine…