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RPH-104 80 mg for Heart Attack

Phase 2
Waitlist Available
Research Sponsored by R-Pharm Overseas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 until day 365
Awards & highlights

Study Summary

This trial will evaluate the effect of RPH-104 on inflammation and disease outcomes in people with STEMI.

Eligible Conditions
  • Heart Attack

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 until day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 until day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14
High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Sensitivity Analysis)
Secondary outcome measures
BNP AUC From Day 1 (Baseline) Until Day 28
Changes in Early Diastolic Transmitral Flow Velocity (E Velocity) Compared to Baseline
Changes in Ejection Fraction (EF) After 12 Months Compared to Baseline
+20 more

Side effects data

From 2020 Phase 2 & 3 trial • 372 Patients • NCT04380519
9%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
2%
Pulmonary embolism
2%
Sepsis
2%
Gamma-glutamyltransferase increased
2%
Acute respiratory distress syndrome
1%
Pericardial effusion
1%
COVID-19
1%
Ventricular fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olokizumab 64 mg
RPH -104 80 mg
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: RPH-104 80 mgExperimental Treatment2 Interventions
subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites
Group II: RPH-104 160 mgExperimental Treatment1 Intervention
subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites
Group III: PlaceboPlacebo Group1 Intervention
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPH-104 80 mg
2020
Completed Phase 3
~480
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

K-ResearchUNKNOWN
R-Pharm Overseas, Inc.Lead Sponsor
2 Previous Clinical Trials
94 Total Patients Enrolled
Cromos Pharma LLCIndustry Sponsor
3 Previous Clinical Trials
212 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Translational MedicineJournal
Interleukin-1 Blockade with RPH-104 in Patients with Acute St-elevation Myocardial Infarction: Study Design and Rationale
Samsonov, M., V. Bogin, B. W. Van Tassell, and A. Abbate. 2021. “Interleukin-1 Blockade with RPH-104 in Patients with Acute St-elevation Myocardial Infarction: Study Design and Rationale”. Journal of Translational Medicine. Springer Science and Business Media LLC. doi:10.1186/s12967-021-02828-z.
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04463251.
~24 spots leftby Apr 2025
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