Ischemic Heart DiseasePhase 1/2LILACSNCT03113773
Low Dose Interleukin-2 in Patients With Stable Ischaemic Heart Disease and Acute Coronary Syndromes
A Phase 1/2 study testing Proleukin in people with Ischemic Heart Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Proleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2017to 21 Feb 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old inclusive
- Previous history (≥ 6 months from planned first day of dosing) of coronary artery disease
- No history of recent (< 6 months from planned first day of dosing) admissions for an unstable cardiovascular event e.g. MI (Myocardial Infarction), unstable angina, ACS
- Written informed consent for participation in the trial
- Part A
- Age 18-85 years old inclusive
Show all 10Show fewer
- Current admission (on at least screening visit) with an acute coronary syndrome (non-ST elevation myocardial infarction, i.e., NSTEMI, or unstable angina) with symptoms of myocardial ischemia lasting 10 minutes or more with the patient at rest or with minimal effort plus either elevated levels of TnI on admission or dynamic changes in ECG (new ST-T changes) or T-wave inversion
- Willingness to be dosed within 8 days from initial date of current admission for ACS
- Written informed consent for participation in the trial
- Part B
Who cannot join
- Current presentation with cardiogenic shock (systolic blood pressure <80 mm Hg, unresponsive to fluids, or necessitating catecholamines), severe congestive heart failure and/or pulmonary oedema
- Known active bleeding or bleeding diatheses
- Known active infection requiring antibiotic treatment
- Severe hematologic abnormalities (haematocrit <30% AND platelet cell count of <100 × 10^3/μL AND white blood cell count <3.3 × 10^3/μL )
- Known malignancies requiring active treatment or follow up (However, patients with current/a history of localised basal or squamous cell skin cancer are not excluded from participation in this trial)
- Known heart failure with impaired LV function: echocardiographic findings of LV EF < 45%
Show all 63Show fewer
- Hypotension (Systolic BP<100mm Hg, DBP<50mmHg) at screening
- Uncontrolled hypertension (>160/100 mmHg) at screening
- History of recurrent syncope (Electrocardiographic history suggestive of arrhythmia syncope (e.g. bifascicular block, sinus bradycardia < 40 beats per minute in absence of sinoatrial block or medications, pre-excited QRS complex, abnormal QT interval, ST segment elevation leads V1 through V3 [Brugada syndrome], negative T wave in right precordial leads and epsilon wave [arrhythmogenic right ventricular dysplasia/cardiomyopathy]))
- Known hepatic failure or abnormal LFTs at baseline (ALT > 2 x ULN).
- Elevated Total Bilirubin Levels, (TBL > 1.5 x ULN) and Alkaline Phosphatase, ALP (ALP > 1.5 x ULN), at baseline
- Acute kidney injury or chronic kidney disease at Stage > 3B (eGFR < 45)
- Respiratory failure
- History of drug induced Stevens Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), toxic epidermal necrolysis, or contrast allergy (requiring steroid treatment)
- History of recurrent epileptic seizures in the previous 4 years; repetitive or difficult to control seizures, coma or toxic psychosis lasting >48 hours
- If known diabetic, uncontrolled diabetes defined as HbA1c > 64 mmol/mol
- Average corrected QT interval (QTc) > 450 msecs using Bazett's formula using triplicate ECGs (or > 480 msecs if bundle branch block)
- Known chronic active hepatitis (B or C)
- Known HIV infection
- Current infection possibly related to recent or on-going immunosuppressive treatment
- Known autoimmune disease requiring active immunosuppressive therapy
- History of organ transplantation
- Any oral or intravenous Immunosuppressive treatment including Prednisolone, hydrocortisone or disease modifying drugs such as Azathioprine, interferon-alpha, Cyclophosphamide or Mycophenolate. [Other immunosuppressive therapies should be discussed with PI. Inhaled or topical steroids are permissible.]
- Known pregnancy at screening or visit 2 (where applicable)
- On-going lactation
- Inability to comply with trial procedures
- Current participation in the active dosing phase of other interventional clinical trials
- Contra indication to IL-2 treatment or hypersensitivity to IL-2 or to any of its excipients
- Unwillingness or inability to provide written informed consent for participation
- Known hyper- or hypothyroidism
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator/delegate and/or medical monitor to make the patient ineligible for inclusion because of a safety concern
- Part B
- ST elevation myocardial infarction (heart attack) on this admission.
- Current presentation with cardiogenic shock (systolic blood pressure <80 mm Hg, unresponsive to fluids, or necessitating catecholamines), electrical instability, severe congestive heart failure and/or pulmonary oedema
- Known active bleeding or bleeding diatheses
- Known active infection requiring antibiotic treatment
- Severe hematologic abnormalities (haematocrit <30% AND platelet cell count of <100 × 10^3/μL, white blood AND cell count <3.3 × 10^3/μL)
- Known malignancies requiring active treatment or follow up (However, patients with current/a history of localised basal or squamous cell skin cancer are not excluded from participation in this trial)
- Known heart failure with impaired LV function: echocardiographic findings of LV EF < 35%
- Hypotension (Systolic BP (SBP)<100mm Hg, DBP<50mmHg) at screening
- Uncontrolled hypertension (>160/100 mmHg) at screening
- History of recurrent syncope (Electrocardiographic history suggestive of arrhythmia syncope (e.g., bifascicular block, sinus bradycardia < 40 beats per minute in absence of sinoatrial block or medications, pre-excited QRS complex, abnormal QT interval, ST segment elevation leads V1 through V3 [Brugada syndrome], negative T wave in right precordial leads and epsilon wave [arrhythmogenic right ventricular dysplasia/cardiomyopathy]))
- Known hepatic failure or abnormal LFTs at baseline (ALT > 2 x ULN).
- Elevated Total Bilirubin Levels, (TBL > 1.5 x ULN) and Alkaline Phosphatase, ALP (ALP > 1.5 x ULN), at baseline
- Renal impairment at screening (Creatinine clearance [Cockcroft-Gault] <45ml/min)
- Acute respiratory failure
- History of drug induced Stevens Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), toxic epidermal necrolysis, or contrast allergy (requiring steroid treatment)
- History of recurrent epileptic seizures in the previous 4 years; repetitive or difficult to control seizures, coma or toxic psychosis lasting >48 hours
- Average corrected QT interval (QTc) > 450 msecs using Bazett's formula using triplicate ECGs (or > 480 msecs if bundle branch block)
- Known chronic active hepatitis (B or C)
- Known HIV infection
- Current infection possibly related to recent or on-going immunosuppressive treatment
- Known autoimmune disease requiring active immunosuppressive therapy
- History of organ transplantation
- Any oral or intravenous immunosuppressive treatment including Prednisolone, hydrocortisone or disease modifying drugs such as Azathioprine, interferon-alpha, Cyclophosphamide or Mycophenolate. [Other immunosuppressive therapies should be discussed with PI. Inhaled or topical steroids are permissible.]
- Known pregnancy at screening (where applicable)
- On-going lactation
- Inability to comply with trial procedures
- Current participation in the active dosing phase of other interventional clinical trials
- Contra indication to IL-2 treatment or hypersensitivity to IL-2 or to any of its excipients
- Unwillingness or inability to provide written informed consent for participation
- Known hyper- or hypothyroidism
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator/delegate and/or medical monitor to make the patient ineligible for inclusion because of a safety concern
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB20QQ
About this study
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.
Read the detailed description
This Phase I/II 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 0.3x10^6 IU up to a maximum of 3.0x10^6 IU (total of 25 completed patients across 5 groups: 3:2 randomisation IL-2:placebo) 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: 6:2 randomisation IL-2:placebo)].
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 occurrence/recurrence of major clinical events.
- Conditions
- Ischemic Heart Disease
- Being tested
- Proleukin, Placebo Injection
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProleukinDrug
Patients will be treated with subcutaneous injections of IL-2 (range 0.3 X 10^6 - 3.0 X 10^6 IU) or placebo once daily for five consecutive days during the trial.A maximum dose of 3.0 X 10^6 IU will be allowed per day.
Placebo InjectionDrug
Dextrose 5%
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Proleukin/Placebo in patients with stable ischaemic heart disease Receives: Drug: Proleukin; Drug: Placebo Injection |
| Part B | Experimental | Proleukin/Placebo in patients with cute coronary syndromes Receives: Drug: Proleukin; Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Determination of IL-2 safety and tolerability parameters
Biochemistry, haematology, ECGs and adverse events will be reviewed throughout the trial
Measured: Through study completion, average of 24 days
Part B - Change in the mean circulating Treg levels (percentage of CD4+ T regulatory defined as CD3+, CD4+, CD25high, CD127low cells within the CD3+, CD4+ T cell gate) following treatment with IL-2.
Percentage change of CD4+ T regulatory cells will be reviewed following treatment with IL-2.
Measured: Measured Days 1 and 6
Part B - Determination of IL-2 safety and tolerability parameters
Biochemistry, haematology, ECGs and adverse events will be reviewed
Measured: Through study completion, average of 24 days
Secondary outcomes (3)
Part B - Changes in circulating cardiac biomarkers (including hs-CRP, IL-6, TnI, BNP)
Circulating cardiac biomarkers (including hs-CRP, IL-6, TnI, BNP)
Measured: Measured Days 1, 6 and between days 10-24
Part B - Change in lymphocyte subsets
Change in lymphocyte subsets
Measured: Measured Days 1 and 6
Part B - Pharmacokinetic analysis of IL-2 levels
PK analysis of IL-2
Measured: Measured Days 1 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start11 May 2017
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBCHB, MA, FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113773
- Sponsor's protocol ID
- LILACS (A093371)
- Acronym
- LILACS
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao TX, Sriranjan RS, Tuong ZK, Lu Y, Sage AP, Nus M, Hubsch A, Kaloyirou F, Vamvaka E, Helmy J, Kostapanos M, Jalaludeen N, Klatzmann D, Tedgui A, Rudd JHF, Horton SJ, Huntly BJP, Hoole SP, Bond SP, Clatworthy MR, Cheriyan J, Mallat Z. Regulatory T-Cell Response to Low-Dose Interleukin-2 in Ischemic Heart Disease. NEJM Evid. 2022 Jan;1(1):EVIDoa2100009. doi: 10.1056/EVIDoa2100009. Epub 2021 Nov 22.
PubMed 38319239Liu L, Hu J, Lei H, Qin H, Wang C, Gui Y, Xu D. Regulatory T Cells in Pathological Cardiac Hypertrophy: Mechanisms and Therapeutic Potential. Cardiovasc Drugs Ther. 2024 Oct;38(5):999-1015. doi: 10.1007/s10557-023-07463-y. Epub 2023 May 15.
PubMed 37184744Zhao TX, Kostapanos M, Griffiths C, Arbon EL, Hubsch A, Kaloyirou F, Helmy J, Hoole SP, Rudd JHF, Wood G, Burling K, Bond S, Cheriyan J, Mallat Z. Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial. BMJ Open. 2018 Sep 17;8(9):e022452. doi: 10.1136/bmjopen-2018-022452.
PubMed 30224390
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Interleukin-2 in Patients With Stable Ischaemic Heart Disease and Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT03113773
- Acronym / sponsor ID
- LILACS / LILACS (A093371)
- Conditions
- Ischemic Heart Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 11 May 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase I/II 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 0.3x10^6 IU up to a maximum of 3.0x10^6 IU (total of 25 completed patients across 5 groups: 3:2 randomisation IL-2:placebo) 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: 6:2 randomisation IL-2:placebo)].
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 occurrence/recurrence of major clinical events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Proleukin, Drug: Placebo InjectionProleukin/Placebo in patients with stable ischaemic heart disease |
| Part B | Experimental | Drug: Proleukin, Drug: Placebo InjectionProleukin/Placebo in patients with cute coronary syndromes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years old inclusive
- Previous history (≥ 6 months from planned first day of dosing) of coronary artery disease
- No history of recent (< 6 months from planned first day of dosing) admissions for an unstable cardiovascular event e.g. MI (Myocardial Infarction), unstable angina, ACS
- Written informed consent for participation in the trial
- Part A
Key exclusion criteria (63 listed)
- Current presentation with cardiogenic shock (systolic blood pressure <80 mm Hg, unresponsive to fluids, or necessitating catecholamines), severe congestive heart failure and/or pulmonary oedema
- Known active bleeding or bleeding diatheses
- Known active infection requiring antibiotic treatment
- Severe hematologic abnormalities (haematocrit <30% AND platelet cell count of <100 × 10^3/μL AND white blood cell count <3.3 × 10^3/μL )
- Known malignancies requiring active treatment or follow up (However, patients with current/a history of localised basal or squamous cell skin cancer are not excluded from participation in this trial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProleukinPatients will be treated with subcutaneous injections of IL-2 (range 0.3 X 10^6 - 3.0 X 10^6 IU) or placebo once daily for five consecutive days during the trial.A maximum dose of 3.0 X 10^6 IU will be allowed per day. | Drug | Part A, Part B |
| Placebo InjectionDextrose 5% | Drug | Part A, Part B |
Primary outcome
Part A - Determination of IL-2 safety and tolerability parameters
Time frame: Through study completion, average of 24 days
Biochemistry, haematology, ECGs and adverse events will be reviewed throughout the trial
Part B - Change in the mean circulating Treg levels (percentage of CD4+ T regulatory defined as CD3+, CD4+, CD25high, CD127low cells within the CD3+, CD4+ T cell gate) following treatment with IL-2.
Time frame: Measured Days 1 and 6
Percentage change of CD4+ T regulatory cells will be reviewed following treatment with IL-2.
Part B - Determination of IL-2 safety and tolerability parameters
Time frame: Through study completion, average of 24 days
Biochemistry, haematology, ECGs and adverse events will be reviewed
3 secondary outcomes
Part B - Changes in circulating cardiac biomarkers (including hs-CRP, IL-6, TnI, BNP)
Time frame: Measured Days 1, 6 and between days 10-24
Part B - Change in lymphocyte subsets
Time frame: Measured Days 1 and 6
Part B - Pharmacokinetic analysis of IL-2 levels
Time frame: Measured Days 1 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 38319239Zhao TX, Sriranjan RS, Tuong ZK, Lu Y, Sage AP, Nus M, Hubsch A, Kaloyirou F, Vamvaka E, Helmy J, Kostapanos M, Jalaludeen N, Klatzmann D, Tedgui A, Rudd JHF, Horton SJ, Huntly BJP, Hoole SP, Bond SP, Clatworthy MR, Cheriyan J, Mallat Z. Regulatory T-Cell Response to Low-Dose Interleukin-2 in Ischemic Heart Disease. NEJM Evid. 2022 Jan;1(1):EVIDoa2100009. doi: 10.1056/EVIDoa2100009. Epub 2021 Nov 22.
- Derived from this study: PubMed 37184744Liu L, Hu J, Lei H, Qin H, Wang C, Gui Y, Xu D. Regulatory T Cells in Pathological Cardiac Hypertrophy: Mechanisms and Therapeutic Potential. Cardiovasc Drugs Ther. 2024 Oct;38(5):999-1015. doi: 10.1007/s10557-023-07463-y. Epub 2023 May 15.
- Derived from this study: PubMed 30224390Zhao TX, Kostapanos M, Griffiths C, Arbon EL, Hubsch A, Kaloyirou F, Helmy J, Hoole SP, Rudd JHF, Wood G, Burling K, Bond S, Cheriyan J, Mallat Z. Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial. BMJ Open. 2018 Sep 17;8(9):e022452. doi: 10.1136/bmjopen-2018-022452.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cheriyan, MBCHB, MA, FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proleukin in people with Ischemic Heart Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 63 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - Determination of IL-2 safety and tolerability parameters (time frame: Through study completion, average of 24 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113773, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.