NCT00542529|CompletedPhase 1/2DMC
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Sponsor study identifier
interventional
66
0 countries
N/A
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2006
Actual (reported)This study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo in varied dosing regimens with granulocyte-colony stimulating factor (G-CSF).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2006
Actual (reported)October 10, 2007
Actual (reported)October 11, 2007
Actual (reported)-To determine the safety of Imprime PGG when dosed as part of a standard 4-day regimen of G-CSF assessed via occurrence of adverse events and change from baseline in clinical laboratories, physical examination, vital signs and ECG
Prospective
-To evaluate the progenitor cell mobilizing efficacy of Imprime PGG when dosed as part of a standard 4-day progenitor cell mobilizing regimen of G-CSF assessed through peripheral blood CD34+ cell counts
Prospective
Placebo or 2.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days.
Placebo or 4.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days.
Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
66 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
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Study Completion
December 2006
Actual (reported)Last Updated
October 11, 2007
Record last verified: 2007-10
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Source: ClinicalTrials.gov.
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