Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-04 @ 3:11 AM
Study NCT ID:
NCT04463251
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2020-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction
Sponsor:
R-Pharm Overseas, Inc.
Organization:
Study Overview
Official Title:
International, Double Blind, Randomized, Placebo-controlled Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of the study was to evaluate the effect of single administration of RPH-104 at 80 mg and 160 mg on parameters of systemic inflammation and outcomes of the disease in subjects with ST-segment elevation myocardial infarction (STEMI)
Detailed Description:
After signing the informed consent form, the investigator assessed the subject's eligibility for the study. The following procedures were performed during the screening: collection of medical history, recording previous and concomitant therapy, demographic data, recording 12-lead ECG findings on which STEMI diagnosis was based, recording date and time of STEMI symptom development, recording date, time and results of coronary angiography (CAG) at admission to the study site, measurement of blood neutrophil count, vital signs, physical examination including measurement of body weight (if hospital bed is available), blood sampling for hematology, biochemistry, determination of concentration of hsCRP and brain natriuretic peptide (BNP; N-terminal (NT)-pro hormone brain natriuretic peptide (NT-pro-BNP)), for females with retained reproductive potential - pregnancy test (test strips).
The subjects meeting selection criteria were randomized to one of the three groups (in 1:1:1 ratio) for single subcutaneous administration of RPH-104 80 mg, RPH-104 160 mg or placebo.
Screening, randomization and administration of the study products were made on the same (first) study day.
Further 4-week (28-day) clinical follow-up and additional 6- and 12-month clinical follow-up period were performed.
The end of clinical part of the study was the date of the last visit of the last subject within additional 12-month clinical follow-up.
The maximum number of screened patients was planned to be 146 subjects, 102 subjects were randomized, 34 subjects per group.
The subjects meeting selection criteria were randomized to one of the three groups (in 1:1:1 ratio) for single subcutaneous administration of RPH-104 80 mg, RPH-104 160 mg or placebo.
Screening, randomization and administration of the study products were made on the same (first) study day.
Further 4-week (28-day) clinical follow-up and additional 6- and 12-month clinical follow-up period were performed.
The end of clinical part of the study was the date of the last visit of the last subject within additional 12-month clinical follow-up.
The maximum number of screened patients was planned to be 146 subjects, 102 subjects were randomized, 34 subjects per group.
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?: