At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 301 enrolled
Drug / intervention
Adrecizumab +1 morebiological
Likely dose
Adrecizumab 2 mg/kgfrom 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.
A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients With Septic Shock and Elevated Adrenomedullin
In Brief
A Phase 2 clinical trial evaluating Adrecizumab and Placebo for Septic Shock. Completed, enrolled 301 participants across 30 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesBelgium, France, Germany, Netherlands
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartDec 2017
Primary CompletionDec 2019
TodayJul 2026
First PostedMar 21, 2017
Enrollment StartDec 12, 2017
Primary CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.3 years ago
Interventions
Adrecizumabbiological
Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)
Placebobiological
Single i.v. dose of placebo (control group)