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Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels

NCT00671307 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-09-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

rhu-pGelsolin

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

DRUG

Placebo

Vehicle control given as IV infusion over 1 hour

Sponsors & Collaborators

  • Critical Biologics Corporation

    lead INDUSTRY

Principal Investigators

  • Wai M Chan, MBBS · Queen Mary Hospital, Hong Kong

  • Selene Tam, PhD · University of Hong Kong; Clinical Trials Centre

  • Richard C Straube, MD · Critical Biologics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671307 on ClinicalTrials.gov