Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT01311518
Status:
WITHDRAWN
Last Update Posted:
2021-09-22
First Post:
2011-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction
Sponsor:
RegeneRx Biopharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-Controlled, Study of the Safety and Efficacy of RGN-352 in Subjects With an Acute ST Elevation Myocardial Infarction (STEMI) After Occlusion of the Proximal Left Anterior Descending Coronary Artery
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial never initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the safety and tolerability of two active doses of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial infarction receiving percutaneous coronary intervention angioplasty with or without stent placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 more weeks.
Detailed Description:
This is a double-blind, placebo controlled, parallel-group, dose finding study. Eligible subjects will be randomized to receive one of two doses of RGN-352 or matching placebo with an equal allocation ratio (i.e., 1:1:1). Approximately 75 subjects will be randomized to study treatment to achieve at least 60 evaluable subjects with 20 to 25 subjects per group. Subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 consecutive weeks. Study subjects will undergo cardiac angiography to assess initial coronary artery patency and Thrombolysis In Myocardial Infarction flow grade both pre- and post-percutaneous coronary intervention (PCI) angioplasty. A total of 7 doses will be administrated over the treatment period. The first dose of either RGN-352 or placebo will be administered to randomized subjects following PCI angioplasty and specifically within 30 minutes after balloon deflation, with a further 2 doses. The remaining 4 doses will be given weekly for 4 consecutive weeks. Follow-up is on Months 2, 4, and 6.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: