Overview

Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury

Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
Severe Traumatic Brain Injury (s-TBI) is a major cause of death and disability across all ages. Besides the primary impact, the pathophysiologic process of major secondary brain damage consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system is therefore considered to be a potentially important new treatment for TBI, as has been shown in animal studies. This trial aims to study the safety and efficacy of C1-inhibitor compared to placebo in TBI patients. By temporarily blocking the complement system we hypothesize limitation of secondary brain injury and more favourable clinical outcome for TBI patients due to a decrease in the posttraumatic neuroinflammatory response.
Phase:
Phase 2
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Netherlands Brain Foundation
Takeda
Treatments:
Complement C1 Inhibitor Protein