CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 target
Drug / intervention
rhu-pGelsolin +1 moredrug
Likely dose
rhu-pGelsolin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00671307
NCT00671307Phase 2Completed
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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

Critical Biologics Corporation·interventional·Posted May 5, 2008·Updated Sep 29, 2010

In Brief

A Phase 2 clinical trial evaluating rhu-pGelsolin and Placebo for Low Gelsolin and 3 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Gelsolin, Trauma, Infection, Burns
CountriesHong Kong
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2008
Enrollment StartMar 1, 2008
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.2 years ago

Interventions

rhu-pGelsolindrug

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

Placebodrug

Vehicle control given as IV infusion over 1 hour