Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640777
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Efficacy and Safety of LEAF-4L6715 for Acute Respiratory Distress Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Randomized Open-Label Phase 3 Study to Investigate Efficacy and Safety of Liposomal TranscrocetinLEAF-4L6715 Plus Standard of Care Vs Standard of Care Alone for Treatment of Patients with Acute Respiratory Distress Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute Respiratory Distress Syndrome ARDS is a serious condition where people in hospital care suddenly have trouble breathing because of infection pneumonia COVID-19 or other disease People with ARDS may have to be put in an intensive care unit ICU and on a ventilator to help them breathe This trial is to try to find out if injecting a product called LEAF-4L6715 makes the treatment better or worse than what is normally given LEAF-4L6715 is a product that contains tiny bubbles to slowly release a substance named transcrocetin which scientific studies show may increase oxygen flow and reduce inflamed cells and protect tissues of the body
Detailed Description:
Study Design Prospective international multicenter open label randomized controlled two-arm study
Study Objectives The 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 Acute Respiratory Distress Syndrome ARDS compared to SOC treatment alone
The 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
Rationale The scientific and clinical observations to date strongly suggest that transcrocetin TC may be a good candidate for the treatment of hypoxic conditions such as moderate to severe ARDS Indeed TC plays a major role in enhancing oxygen diffusion but also in reducing inflammation and protecting tissues However TCs poor stability and solubility and its short in vivo half-life of 30mins resulted in transient oxygenation effect LEAF-4L6715 was designed to be a stable TC formulation with a 6-fold increase in half-life and a 12-fold increase in drug exposure compared to free TC resulting in a more sustained oxygenation compared with free TC
Developed as a liposomal formulation of TC LEAF-4L6715 allows for a gradual release of the free drug and was evaluated at multiple levels 1 in vitro in Human Umbilical Vein Endothelial Cells HUVECs 2 in vivo in healthy mice n40 as well as in a mouse model of sepsis n10 and 3 in a clinical trial evaluating Pharmacokinetics PK and safety A phase 12 trial which included 37 patients defined the optimal dose regimen and intravenous infusion timing and confirmed the safety of LEAF-4L6715 It also showed promising trends in therapeutic efficacy
Study Objectives The 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 Acute Respiratory Distress Syndrome ARDS compared to SOC treatment alone
The 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
Rationale The scientific and clinical observations to date strongly suggest that transcrocetin TC may be a good candidate for the treatment of hypoxic conditions such as moderate to severe ARDS Indeed TC plays a major role in enhancing oxygen diffusion but also in reducing inflammation and protecting tissues However TCs poor stability and solubility and its short in vivo half-life of 30mins resulted in transient oxygenation effect LEAF-4L6715 was designed to be a stable TC formulation with a 6-fold increase in half-life and a 12-fold increase in drug exposure compared to free TC resulting in a more sustained oxygenation compared with free TC
Developed as a liposomal formulation of TC LEAF-4L6715 allows for a gradual release of the free drug and was evaluated at multiple levels 1 in vitro in Human Umbilical Vein Endothelial Cells HUVECs 2 in vivo in healthy mice n40 as well as in a mouse model of sepsis n10 and 3 in a clinical trial evaluating Pharmacokinetics PK and safety A phase 12 trial which included 37 patients defined the optimal dose regimen and intravenous infusion timing and confirmed the safety of LEAF-4L6715 It also showed promising trends in therapeutic efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None