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Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

NCT03085758 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-02-21

Study results available
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Summary

This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of \> 70 pg/ml.

Conditions

  • Septic Shock

Interventions

BIOLOGICAL

Adrecizumab

Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)

BIOLOGICAL

Placebo

Single i.v. dose of placebo (control group)

Sponsors & Collaborators

  • Adrenomed AG

    lead INDUSTRY

Principal Investigators

  • Jens Zimmermann, Dr. · Adrenomed AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Belgium
  • France
  • Germany
  • Netherlands

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 NCT03085758 on ClinicalTrials.gov