Status:
COMPLETED
Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels
Lead Sponsor:
Critical Biologics Corporation
Conditions:
Low Gelsolin
Trauma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Un...
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 ac...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00671307
Start Date
March 1 2008
End Date
May 1 2010
Last Update
September 29 2010
Active Locations (1)
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1
Queen Mary Hospital; University of Hong Kong
Hong Kong, SAR, Hong Kong