Acute Myocardial InfarctionPhase 2NCT05984134
Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction
A Phase 2 study testing NL005 Middle Dose and NL005 High Dose in people with Acute Myocardial Infarction, run by Beijing Northland Biotech. Co., Ltd. at 1 site in China.
Trial summary
A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a ratio of 1:1:1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- NL005 Middle Dose and NL005 High Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 29 May 2023
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects or their guardians voluntarily participate in the experiment and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- STEMI patients with proximal or/and middle occlusion of a single left anterior descending artery (TIMI grade 0-1) and PCI;
- No coronary collateral (Rentrop grade 0);
- meet one of the following conditions:
- The total myocardial ischemia time before PCI was < 6 hours, and the TIMI grade after PCI was < 3
- 6 hours ≤ Total myocardial ischemia time before PCI ≤24 hours Note: Total myocardial ischemia time =PCI wire passage time - start time of chest pain
- All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier methods, abstinence) during study participation and up to 6 months of the last dosing, and women of childbearing age must test negative for pregnancy before dosing.
Who cannot join
- Patients with a history of myocardial infarction who have received acute coronary thrombolysis, interventional therapy, or bypass surgery; A clear diagnosis of acute heart failure (Killip grade ≥III);
- Severe arrhythmias that cannot be corrected;
- Aortic dissection;
- Severe liver and kidney dysfunction or severe consumption;
- History of major surgery or hemorrhagic stroke within six months;
- Previous history of malignant tumors;
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- Hypertensive patients with systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg after active antihypertensive treatment;
- Clinically significant allergic reaction history, especially mannitol, drugs, protein preparations, biological products;
- Patients who participated in other clinical studies within 3 months prior to screening;
- Can not perform CMR examination;
- Other conditions deemed unsuitable for inclusion by the investigators (for example, those whose coronary arteries other than the left anterior descending branch were judged by the investigators to require elective revascularization therapy at the same time or within 1 month).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Recombinant Human Thymosin β4(NL005) for Injection in Patients With Acute Myocardial Infarction: a Phase IIb Clinical Study
A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a ratio of 1:1:1. After randomization, subjects received the trial drug or placebo intravenously within 12 hours and on days 2 to 7 after PCI. The patients were observed 90 days after PCI.
Read the detailed description
Cardiovascular magnetic resonance imaging (CMR) was performed on day 5 and day 90 after PCI to evaluate myocardial infarction size, microvascular obstruction area, left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV). Physical examination, blood routine examination, and coagulation function examination were performed before the first dose, on the 7th, 30th, and 90th day after PCI. The examination before the first dose was conducted to accept the examination results from the current onset to the first dose.Electrocardiogram (ECG) was performed before the first dose, day 2, day 7, day 30, and day 90 after PCI, and the test results from the period after PCI to the first dose were received. Vital signs were examined before the first dose, day 1 to day 7, day 30, and day 90 after PCI, and the results of the examination from the first onset to the first dose were accepted during the examination before the first dose. Blood biochemical tests were performed before the first dose, from day 2 to day 4, day 7, day 30, and day 90 after PCI. The results of the examinations from the first onset to the first dose were accepted during the examination before the first dose. High-sensitivity troponin I(hs-cTnI) or troponin I(cTnI) and amino-terminal B-type natriuretic peptide precursor (NT-proBNP) or B-type natriuretic peptide (BNP) were tested before first administration and on days 2, 3, 4, and 7 after PCI. Examination results from the time after PCI to the time before initial administration; Creatine kinase isoenzyme (CK-MB) tests were performed before the first dose, 12 hours after the first dose, day 2 (if it coincided with 12 hours after the first dose, no repeat blood collection was required), day 3, and day 4. The test results from the period after PCI to the period before the first dose were accepted. Tumor markers were detected and immunogenic blood samples were collected before the first dose and on the 30th day after PCI. The tumor markers were examined before the first dose. Urine routine examination was performed before the first dose and on the 90th day after PCI. The examination before the first dose accepted the examination results from the onset of the disease to the first dose. Drug combinations, adverse events, and cardiovascular events were recorded during the trial.
- Conditions
- Acute Myocardial Infarction
- Being tested
- NL005 Middle Dose, NL005 High Dose, Placebo
- Keywords
- CMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NL005 Middle DoseDrug
Also called NL005（ Middle Dose）
Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.
NL005 High DoseDrug
Also called NL005（ High Dose）
Patients in this treatment group will receive NL005 for 1.5 ug/kg respective.Continuous administration for 7 days.
PlaceboDrug
30 subjects will be randomly assigned to the placebo for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Middle Dose | Experimental | 12 hours after PCI: 0.5 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：0.5 ug/kg Recombinant Human Thymosin β4 （intravenous injection） Receives: Drug: NL005 Middle Dose |
| High Dose | Experimental | 12 hours after PCI: 1.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：1.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection） Receives: Drug: NL005 High Dose |
| Placebo | Placebo comparator | Patients in this treatment group will receive placebo respective. Continuous administration for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of myocardial infarction area
The percentage of myocardial infarction area was defined as the percentage of CMR delayed enhancement area in the entire left ventricular myocardium as measured by plane geometry of computer-assisted enhanced myocardium.Percentage change of myocardial infarction size =D5 percentage of myocardial infarction size -D90 percentage of myocardial infarction size
Measured: Day 5、Day 90
Secondary outcomes (8)
Myocardial mass (g)
Myocardial infarction area was defined as CMR delayed enhancement area, and myocardial mass (g) were calculated , and determined by plane geometry method of computer-aided enhanced myocardium. Myocardial infarction size change =D5 myocardial infarction size -D90 myocardial infarction size.
Measured: Day 5、Day 90
Myocardial volume (ml)
Myocardial infarction area was defined as CMR delayed enhancement area, and volume (ml) were calculated, and determined by plane geometry method of computer-aided enhanced myocardium.Myocardial infarction size change =D5 myocardial infarction size -D90 myocardial infarction size.
Measured: Day 5、Day 90
Myocardial microvessel obstruction area change value
Myocardial microvessel obstruction area change value =D5 microvessel obstruction area -D90 microvessel obstruction area
Measured: Day 5、Day 90
The change of CK-MB before and after administration
CK-MB change value = CK-MB value before administration - CK-MB value after administration
Measured: Before the first dose, 12 hours after the first dose, day 2, day 3, day 4
The area under the CK-MB curve within 4 days
CK-MB change value = CK-MB value before administration - CK-MB value after administration
Measured: Before the first dose, 12 hours after the first dose, day 2, day 3, day 4
Changes of left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) change =D90 LVEF-D5 LVEF
Measured: Day 5、Day 90
Changes of left ventricular end-systolic volume (LVESV)
Left ventricular end-systolic volume (LVESV) change =D90 LVESV-D5 LVESV
Measured: Day 5、Day 90
Changes of left ventricular end-diastolic volume (LVEDV)
Left ventricular end-diastolic volume (LVEDV) change = D90 LVEDV-D5 LVEDV
Measured: Day 5、Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Jul 2022
- Primary completion26 May 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KeFei Dou, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984134
- Sponsor's protocol ID
- NL005-AMI-IIb
- Status last verified
- Jun 2024
- First submitted
- 20 Jul 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Recombinant Human Thymosin β4(NL005) for Injection in Patients With Acute Myocardial Infarction: a Phase IIb Clinical Study
- ClinicalTrials.gov ID
- NCT05984134
- Acronym / sponsor ID
- NL005-AMI-IIb
- Conditions
- Acute Myocardial Infarction
- Keywords
- CMR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 9 Aug 2023 (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.
A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a ratio of 1:1:1. After randomization, subjects received the trial drug or placebo intravenously within 12 hours and on days 2 to 7 after PCI. The patients were observed 90 days after PCI.
Detailed description
Cardiovascular magnetic resonance imaging (CMR) was performed on day 5 and day 90 after PCI to evaluate myocardial infarction size, microvascular obstruction area, left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV). Physical examination, blood routine examination, and coagulation function examination were performed before the first dose, on the 7th, 30th, and 90th day after PCI. The examination before the first dose was conducted to accept the examination results from the current onset to the first dose.Electrocardiogram (ECG) was performed before the first dose, day 2, day 7, day 30, and day 90 after PCI, and the test results from the period after PCI to the first dose were received. Vital signs were examined before the first dose, day 1 to day 7, day 30, and day 90 after PCI, and the results of the examination from the first onset to the first dose were accepted during the examination before the first dose. Blood biochemical tests were performed before the first dose, from day 2 to day 4, day 7, day 30, and day 90 after PCI. The results of the examinations from the first onset to the first dose were accepted during the examination before the first dose. High-sensitivity troponin I(hs-cTnI) or troponin I(cTnI) and amino-terminal B-type natriuretic peptide precursor (NT-proBNP) or B-type natriuretic peptide (BNP) were tested before first administration and on days 2, 3, 4, and 7 after PCI. Examination results from the time after PCI to the time before initial administration; Creatine kinase isoenzyme (CK-MB) tests were performed before the first dose, 12 hours after the first dose, day 2 (if it coincided with 12 hours after the first dose, no repeat blood collection was required), day 3, and day 4. The test results from the period after PCI to the period before the first dose were accepted. Tumor markers were detected and immunogenic blood samples were collected before the first dose and on the 30th day after PCI. The tumor markers were examined before the first dose. Urine routine examination was performed before the first dose and on the 90th day after PCI. The examination before the first dose accepted the examination results from the onset of the disease to the first dose. Drug combinations, adverse events, and cardiovascular events were recorded during the trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Middle Dose | Experimental | Drug: NL005 Middle Dose12 hours after PCI: 0.5 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：0.5 ug/kg Recombinant Human Thymosin β4 （intravenous injection） |
| High Dose | Experimental | Drug: NL005 High Dose12 hours after PCI: 1.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：1.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection） |
| Placebo | Placebo comparator | Drug: PlaceboPatients in this treatment group will receive placebo respective. Continuous administration for 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subjects or their guardians voluntarily participate in the experiment and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- STEMI patients with proximal or/and middle occlusion of a single left anterior descending artery (TIMI grade 0-1) and PCI;
- No coronary collateral (Rentrop grade 0);
- meet one of the following conditions:
Key exclusion criteria (11 listed)
- Patients with a history of myocardial infarction who have received acute coronary thrombolysis, interventional therapy, or bypass surgery; A clear diagnosis of acute heart failure (Killip grade ≥III);
- Severe arrhythmias that cannot be corrected;
- Aortic dissection;
- Severe liver and kidney dysfunction or severe consumption;
- History of major surgery or hemorrhagic stroke within six months;
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 |
|---|---|---|
| NL005 Middle DoseAlso: NL005（ Middle Dose）Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days. | Drug | Middle Dose |
| NL005 High DoseAlso: NL005（ High Dose）Patients in this treatment group will receive NL005 for 1.5 ug/kg respective.Continuous administration for 7 days. | Drug | High Dose |
| Placebo30 subjects will be randomly assigned to the placebo for 7 days | Drug | Placebo |
Primary outcome
Percentage change of myocardial infarction area
Time frame: Day 5、Day 90
The percentage of myocardial infarction area was defined as the percentage of CMR delayed enhancement area in the entire left ventricular myocardium as measured by plane geometry of computer-assisted enhanced myocardium.Percentage change of myocardial infarction size =D5 percentage of myocardial infarction size -D90 percentage of myocardial infarction size
8 secondary outcomes
Myocardial mass (g)
Time frame: Day 5、Day 90
Myocardial volume (ml)
Time frame: Day 5、Day 90
Myocardial microvessel obstruction area change value
Time frame: Day 5、Day 90
The change of CK-MB before and after administration
Time frame: Before the first dose, 12 hours after the first dose, day 2, day 3, day 4
The area under the CK-MB curve within 4 days
Time frame: Before the first dose, 12 hours after the first dose, day 2, day 3, day 4
Changes of left ventricular ejection fraction (LVEF)
Time frame: Day 5、Day 90
Changes of left ventricular end-systolic volume (LVESV)
Time frame: Day 5、Day 90
Changes of left ventricular end-diastolic volume (LVEDV)
Time frame: Day 5、Day 90
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 21 Jun 2024.
- Individual participant dataSharing planned: No
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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.
KeFei Dou principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NL005 Middle Dose and NL005 High Dose in people with Acute Myocardial Infarction, run by Beijing Northland Biotech. Co., Ltd. at 1 site in China.
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 8 inclusion and 11 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 21 Jun 2024. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Percentage change of myocardial infarction area (time frame: Day 5、Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.