Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels
NCT ID: NCT00671307
Last Updated: 2010-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2008-03-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Vehicle control given as IV infusion over 1 hour
Low dose
3 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Mid-dose
6 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
High dose
6 mg/kg of rhu-pGelsolin given a an IV infusion over 1 hour once a day for 3 days
rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Interventions
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rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Placebo
Vehicle control given as IV infusion over 1 hour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Critical Biologics Corporation
INDUSTRY
Responsible Party
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Critical Biologics Corporation
Principal Investigators
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Wai M Chan, MBBS
Role: PRINCIPAL_INVESTIGATOR
Queen Mary Hospital, Hong Kong
Selene Tam, PhD
Role: STUDY_DIRECTOR
University of Hong Kong; Clinical Trials Centre
Richard C Straube, MD
Role: STUDY_CHAIR
Critical Biologics Corporation
Locations
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Queen Mary Hospital; University of Hong Kong
Hong Kong, SAR, Hong Kong
Countries
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References
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Lee PS, Waxman AB, Cotich KL, Chung SW, Perrella MA, Stossel TP. Plasma gelsolin is a marker and therapeutic agent in animal sepsis. Crit Care Med. 2007 Mar;35(3):849-55. doi: 10.1097/01.CCM.0000253815.26311.24.
Lee PS, Drager LR, Stossel TP, Moore FD, Rogers SO. Relationship of plasma gelsolin levels to outcomes in critically ill surgical patients. Ann Surg. 2006 Mar;243(3):399-403. doi: 10.1097/01.sla.0000201798.77133.55.
Christofidou-Solomidou M, Scherpereel A, Solomides CC, Christie JD, Stossel TP, Goelz S, DiNubile MJ. Recombinant plasma gelsolin diminishes the acute inflammatory response to hyperoxia in mice. J Investig Med. 2002 Jan;50(1):54-60. doi: 10.2310/6650.2002.33518.
Rothenbach PA, Dahl B, Schwartz JJ, O'Keefe GE, Yamamoto M, Lee WM, Horton JW, Yin HL, Turnage RH. Recombinant plasma gelsolin infusion attenuates burn-induced pulmonary microvascular dysfunction. J Appl Physiol (1985). 2004 Jan;96(1):25-31. doi: 10.1152/japplphysiol.01074.2002. Epub 2003 May 2.
Mounzer KC, Moncure M, Smith YR, Dinubile MJ. Relationship of admission plasma gelsolin levels to clinical outcomes in patients after major trauma. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1673-81. doi: 10.1164/ajrccm.160.5.9807137.
DiNubile MJ, Stossel TP, Ljunghusen OC, Ferrara JL, Antin JH. Prognostic implications of declining plasma gelsolin levels after allogeneic stem cell transplantation. Blood. 2002 Dec 15;100(13):4367-71. doi: 10.1182/blood-2002-06-1672. Epub 2002 Aug 1.
Suhler E, Lin W, Yin HL, Lee WM. Decreased plasma gelsolin concentrations in acute liver failure, myocardial infarction, septic shock, and myonecrosis. Crit Care Med. 1997 Apr;25(4):594-8. doi: 10.1097/00003246-199704000-00007.
Other Identifiers
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CBC101
Identifier Type: -
Identifier Source: org_study_id