NCT04463251

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: R-Pharm Overseas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	RPH-104 80 mg	solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial
DRUG	Placebo	Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-11-03
• Completion: 2022-10-10
• First posted: 2020-07-09
• Last updated: 2024-06-24
• Results posted: 2024-01-24

Locations

11 sites across 2 countries: United States, Russia

Regulatory

• FDA-regulated drug study