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

Phase 1

Completed

• Conditions: Low Gelsolin; Trauma; Infection; Burns
• Interventions: Drug: Placebo; Drug: rhu-pGelsolin

• Registration Number: NCT00671307
• Lead Sponsor: Critical Biologics Corporation

Brief 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.

Detailed Description

This is a randomized, double-blind, placebo-controlled, ascending single dose of rhu-pGelsolin infusion study. Thirteen subjects (10 active and 3 placebo) will be dosed at 3 mg/kg and 5 subjects (3 active and 2 placebo) will be dosed at 6 mg/kg. In addition, twenty-two subjects (18 active and 4 placebo) will be dosed at 6 mg/kg per day for 3 days. The Data Safety Monitoring Committee (DSMC) and Steering Committee will review the preceding dose safety data, and agree the tolerability prior to the enrolment for next higher dose. Blood samples will be collected during 1 hour infusion through 72 hours post dose for PK assessment after each dose.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-05
• Primary Completion: 2010-03
• Status Verified: 2010-04
• Study Completion: 2010-05
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Low dose	rhu-pGelsolin	3 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
Mid-dose	rhu-pGelsolin	6 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
High dose	rhu-pGelsolin	6 mg/kg of rhu-pGelsolin given a an IV infusion over 1 hour once a day for 3 days

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of plasma gelsolin	72 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events and the development of anti-rhu-pGelsolin antibodies	3 months
Pharmacodynamics of sepsis biomarkers	72 hours
Clinical outcomes (mortality, duration of ICU stay, duration of ventilator support, duration of hospital stay)	28 days

Trial Locations

Locations (1)

Queen Mary Hospital; University of Hong Kong; 🇭🇰 Hong Kong, SAR, Hong Kong