Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the pharmacokinetics and safety of an infusion of a single dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the Intensive Care Unit with documented low levels of natural gelsolin. It is believed that this drug will raise the gelsolin levels in these patients and decrease the probability that they will develop complications from their underlying disease such as organ system failure or death.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Critical Biologics Corporation

Criteria

Inclusion Criteria:

• >18 years of age

• Documented gelsolin level <100 mg/mL

• Admission to ICU

• Women of child-bearing age have a negative pregnancy test

• Multiple Organ Failure score < 4

• Catheter present through which blood samples can be taken

• Written Informed Consent obtained

Exclusion Criteria:

• Participation in other investigational treatment protocols

• Patients <18 years of age

• Patients who have a modified Multiple Organ Failure score of >=4

• Patient, who in the opinion of the Principal Investigator, are unlikely to be in the ICU for >48 hours