Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03113773
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2017-03-14
Brief Title:
Low Dose Interleukin-2 in Patients With Stable Ischaemic Heart Disease and Acute Coronary Syndromes
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Low Dose Interleukin-2 in Patients With Stable Ischaemic Heart Disease and Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LILACS
Brief Summary:
The mainstay for treatment for acute coronary syndrome ACS focusses on re-establishing and maintaining the patency of vessels following coronary plaque disruption through the use of anti-platelets and anticoagulants Despite advances in management ACS still carries a high risk of morbidity and mortality thus future management is likely to target other pathways
Recent studies indicate that CD4 T cells and more specifically Treg cells are important for the control of post-ischemic immune responses and the promotion of myocardial healing The investigators therefore hypothesise that expansion of Treg cells in patients with ACS dampens the activation of the immune response and promotes both plaque and myocardial healing The investigators hypothesise that this can be achieved through subcutaneous administration of low doses of interleukin-2 IL-2 IL-2 supplementation appears to be an attractive therapeutic option playing a key role in Treg cell development expansion survival and suppressive function
Recent studies indicate that CD4 T cells and more specifically Treg cells are important for the control of post-ischemic immune responses and the promotion of myocardial healing The investigators therefore hypothesise that expansion of Treg cells in patients with ACS dampens the activation of the immune response and promotes both plaque and myocardial healing The investigators hypothesise that this can be achieved through subcutaneous administration of low doses of interleukin-2 IL-2 IL-2 supplementation appears to be an attractive therapeutic option playing a key role in Treg cell development expansion survival and suppressive function
Detailed Description:
This Phase III trial will carefully examine the safety of low-dose IL-2 in cardiovascular patients where it is currently contraindicated The planned doses will be given to the trial patients once a day over five days as subcutaneous injections i Part A Repeated doses will be given in the range of 03x106 IU up to a maximum of 30x106 IU total of 25 completed patients across 5 groups 32 randomisation IL-2placebo ii Part B Repeated doses will be given at doses not exceeding the maximum dose used in Part A total of 32 completed patients across 4 groups 62 randomisation IL-2placebo
These doses have been chosen on the basis of safety and tolerability data from published clinical studies In the low dose IL-2 studies evaluated there were a low rate of adverse events AEs in all of the studies with the most commonly reported AEs being injection site reactions fatigue fever nausea and vomiting A low percentage of serious adverse events SAEs were recorded in a GVHD graft-versus-host disease-risk study and these SAEs included haemorrhage CNS anorexia and infection colitis
The experimental and clinical background in low-dose IL-2 therapy suggests a potential clinical utility of Treg cell expansion in patients with ACS Administration of low doses of IL-2 in various clinical settings appears to be safe and remarkably efficacious at promoting selective expansion of Treg cells with preserved suppressive function This is the first trial to assess the mechanism of action of IL-2 therapy in cardiovascular patients The aim of Part A of this clinical trial is to assess the safety of low-dose IL-2 as well as the proof of mechanism in patients with stable ischaemic heart disease Part B aims to assess the safety and efficacy of and increase in Treg as a result of this drug supplementation in the setting of ACS
The investigators hypothesize that low doses of IL-2 in patients with ACS can increase Treg number and function and ultimately promote plaque stabilisation and myocardial healing this will be further addressed in future studies In this context it may improve patient recovery and limit the occurrencerecurrence of major clinical events
These doses have been chosen on the basis of safety and tolerability data from published clinical studies In the low dose IL-2 studies evaluated there were a low rate of adverse events AEs in all of the studies with the most commonly reported AEs being injection site reactions fatigue fever nausea and vomiting A low percentage of serious adverse events SAEs were recorded in a GVHD graft-versus-host disease-risk study and these SAEs included haemorrhage CNS anorexia and infection colitis
The experimental and clinical background in low-dose IL-2 therapy suggests a potential clinical utility of Treg cell expansion in patients with ACS Administration of low doses of IL-2 in various clinical settings appears to be safe and remarkably efficacious at promoting selective expansion of Treg cells with preserved suppressive function This is the first trial to assess the mechanism of action of IL-2 therapy in cardiovascular patients The aim of Part A of this clinical trial is to assess the safety of low-dose IL-2 as well as the proof of mechanism in patients with stable ischaemic heart disease Part B aims to assess the safety and efficacy of and increase in Treg as a result of this drug supplementation in the setting of ACS
The investigators hypothesize that low doses of IL-2 in patients with ACS can increase Treg number and function and ultimately promote plaque stabilisation and myocardial healing this will be further addressed in future studies In this context it may improve patient recovery and limit the occurrencerecurrence of major clinical events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None