Burns, Infection, Low Gelsolin, Trauma
Conditions
Keywords
Gelsolin, Trauma, Pneumonia, Peritonitis, Burn, Infection, Sepsis, Systemic Inflammatory Response Syndrome
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.
Interventions
DRUGrhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
DRUGPlacebo
Vehicle control given as IV infusion over 1 hour
Sponsors
Critical Biologics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of plasma gelsolin | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Hong Kong
Outcome results
None listed