Trial | NCT00671307  Report issue

Title

Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels
Phase 1b Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Infusion Trial of the Pharmacokinetics of Rhu-pGelsolin in Patients With Decreased Natural Gelsolin Levels

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Mar 31
2008
Primary Completion
Mar 31
2010
Study Completion
May 31
2010
Last Update
Sep 29
2010
Estimate

Drug rhu-pGelsolin

IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour

  • Other names: Recombinant plasma gelsolin, CBC-100, Solinex

Drug Placebo

Vehicle control given as IV infusion over 1 hour

  • Other names: Vehicle control

Placebo Placebo Comparator

Placebo

Low dose Experimental

3 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour

Mid-dose Experimental

6 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour

High dose Experimental

6 mg/kg of rhu-pGelsolin given a an IV infusion over 1 hour once a day for 3 days

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
No Results Posted