Trancrocetins (TCs) have been reported to possess the capabilities to increase the diffusion of oxygen in plasma or water. Developed as a liposomal formulation of TC, LEAF-4L6715 allows for a gradual release of the free drug and was evaluated at multiple levels. A phase 1/2 trial including 37 patients not only allowed to define the optimal dose regimen and IV infusion timing and to confirm the safety of LEAF-4L6715, but also showed promising trends in therapeutic efficacy.
A new larger phase 3 randomized trial is needed to confirm the therapeutic efficacy of liposomal TC, LEAF-4L6715, when used to treat patients suffering from Acute Respiratory Distress Syndrome (ARDS). Patients with moderate to severe ARDS could benefit from LEAF-4L6715 reoxygenation and anti-inflammatory properties.
Sponsor
LEAF4Life Inc
Study objectives
Primary objective of the study is to determine if the addition of LEAF-4L6715 to Standard of Care (SOC) treatment may improve clinical outcomes at 30-days, including survival and duration of mechanical ventilation (MV), in patients with ARDS compared to SOC treatment alone.
Secondary objectives are to compare other relevant respiratory and clinical outcomes and safety between the two groups during Intensive Care Unit (ICU) stay, hospitalization, and follow-up, including percentage of patients alive at 60 days and 90 days from randomization.
Primary endpoints
The primary endpoint is a hierarchical criterion assessed at Day 30, including all-cause mortality followed by days free from invasive MV through 30 days, and calculated in such a manner that death constitutes a worse outcome than duration of ventilation.
CERC Services
- CEC and DSMB activities
- EDC and data management
- Final study report
- Health economics analysis
- Monitoring activities
- Project management
- Regulatory submissions
- Safety reporting
- Sites' contract management
- Statistical Activities
- Study documents draft and review
Countries
Up to 4 European countries (including France)
Number of investigational sites
30 sites
