At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
RPH-104 80 mg +1 morebiological
Likely dose
RPH-104 80 mgfrom 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.
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
In Brief
A Phase 2 clinical trial evaluating RPH-104 80 mg and Placebo for Acute ST Segment Elevation Myocardial Infarction. Completed, enrolled 102 participants across 11 sites in 2 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia, United States
CollaboratorsCromos Pharma LLC, Data Management 365, Keystat, LLC, R-Pharm, K-Research, LLC
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartDec 2020
Primary CompletionNov 2021
Study CompletionOct 2022
TodayJul 2026
First PostedJul 9, 2020
Enrollment StartDec 7, 2020
Primary CompletionNov 3, 2021
Study CompletionOct 10, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.0 years ago
Interventions
RPH-104 80 mgbiological
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial
Placebodrug
Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial