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Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema

NCT04898309 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2022-02-04

No results posted yet for this study

Summary

It is a placebo-controlled randomized trial to evaluate the efficacy and safety of GNR-038 in comparison with Berinert® in patients with hereditary angioedema

Conditions

Interventions

DRUG

GNR-038, 50 МЕ/ kg

A single intravenous infusion of GNR-038, 50 МЕ/ kg less than 5 hours after the onset of edema.

DRUG

GNR-038, 100 МЕ/ kg

A single intravenous infusion of GNR-038, 100 МЕ/ kg less than 5 hours after the onset of edema.

DRUG

Berinert®, 20 МЕ/ kg

A single intravenous infusion of Berinert®, 20 МЕ/ kg less than 5 hours after the onset of edema.

DRUG

Placebo

A single intravenous infusion of Placebo less than 5 hours after the onset of edema.

DRUG

GNR-038. The dose will be selected according to results of stage 1 clinical trial.

A single intravenous infusion of GNR-038 less than 5 hours after the onset of edema.

DRUG

Berinert®, 20 МЕ/ kg

A single intravenous infusion of Berinert®, 20 МЕ/ kg less than 5 hours after the onset of edema.

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · AO GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04898309 on ClinicalTrials.gov