NCT04489160

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

A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Severe Traumatic Brain Injury

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury
• Trauma, Head

Interventions

Type	Name	Description
DRUG	C1 Inhibitor, Human	6000 IU C1-INH
DRUG	Placebo	0.9% saline

Timeline

• Start date: 2021-02-25
• Primary completion: 2023-07-01
• Completion: 2024-07-01
• First posted: 2020-07-28
• Last updated: 2021-09-13

Locations

3 sites across 1 country: Netherlands

Regulatory

• FDA-regulated drug study