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Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis

NCT04692766 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-31

No results posted yet for this study

Summary

The goal of this study was to evaluate the Efficacy and Safety of RPH-104 Treatment in patients in comparison to placebo with Idiopathic Recurrent Pericarditis

Conditions

  • Pericarditis

Interventions

BIOLOGICAL

RPH-104

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), 5 mL in a polypropylene ampoule, 10 ampoules per labeled package

Sponsors & Collaborators

  • Unimed Laboratories

    collaborator INDUSTRY

  • Data Management 365

    collaborator INDUSTRY

  • Center of Pharmaceutical Analytics LLC

    collaborator INDUSTRY

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2022-01-24
Completion
2022-03-22

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04692766 on ClinicalTrials.gov