A Phase 1/2 interventional study of rhu-pGelsolin and Placebo in Low Gelsolin, Trauma and Infection, sponsored by Critical Biologics Corporation. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-29.
Sponsored by Critical Biologics Corporation · Phase 1/2, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Critical Biologics Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: Placebo
3 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
Drug: rhu-pGelsolin
6 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
Drug: rhu-pGelsolin
6 mg/kg of rhu-pGelsolin given a an IV infusion over 1 hour once a day for 3 days
Drug: rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Also known as: Recombinant plasma gelsolin, CBC-100, Solinex
Vehicle control given as IV infusion over 1 hour
Also known as: Vehicle control
Pharmacokinetics of plasma gelsolin
Time frame: 72 hours
Adverse events and the development of anti-rhu-pGelsolin antibodies
Time frame: 3 months
Pharmacodynamics of sepsis biomarkers
Time frame: 72 hours
Clinical outcomes (mortality, duration of ICU stay, duration of ventilator support, duration of hospital stay)
Time frame: 28 days
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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