CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Low Dose +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05485818
NCT05485818Phase 2Completed
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Phase IIa Clinical Study of Efficacy and Safety of Injectable Recombinant Human Thymosin Beta 4 in Patients With Acute Myocardial Infarction

Beijing Northland Biotech. Co., Ltd.·interventional·Posted Aug 3, 2022·Updated Aug 3, 2022

In Brief

A Phase 2 clinical trial evaluating Low Dose, Middle Dose, and 2 other interventions for Acute Myocardial Infarction. Completed, enrolled 62 participants across 1 site.

Detailed Summary

A multicenter randomized double-blind placebo parallel control design was used in this study.60 subjects eligible for inclusion will be randomly assigned to either a low-dose (0.25ug/kg) medium-dose (0.5ug/kg) high-dose (2.0ug/kg) experimental drug group or a control group (placebo) at a ratio of 1:1:1:1.After randomization, subjects received the experimental drug or placebo once a day, intravenously, on day 2 to 7, 12 hours and 4 hours after PCI.Ninety days after PCI were observed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 3, 2022
Enrollment StartNov 23, 2020
Primary CompletionSep 30, 2021
Study CompletionNov 18, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.9 years ago

Interventions

Low Dosedrug

12±4 hours after PCI: 0.25 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：0.25 ug/kg Recombinant Human Thymosin β4 （intravenous injection）

Middle Dosedrug

12±4 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 Dosedrug

12±4 hours after PCI: 2.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：2.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection）

Placeboother

15 subjects will be randomly assigned to the placebo for 7 days