At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Nangibotide 0.3 mg/kg +3 moredrug
Likely dose
Nangibotide 0.3 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.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study
In Brief
A Phase 2 clinical trial evaluating Nangibotide 0.3 mg/kg, Placebo, and 2 other interventions for Shock, Septic. Completed, enrolled 50 participants across 4 sites in 4 countries.
Detailed Summary
This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShock, Septic
CountriesBelgium, France, Netherlands, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJul 2017
Primary CompletionJun 2018
TodayJul 2026
First PostedMay 18, 2017
Enrollment StartJul 3, 2017
Primary CompletionJun 13, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.1 years ago
Interventions
Nangibotide 0.3 mg/kgdrug
Formulated LR12 peptide
Placebodrug
placebo
Nangibotide 1 mg/kgdrug
Formulated LR12 peptide
Nangibotide 3 mg/kgdrug
Formulated LR12 peptide