A Phase 1 interventional study of Pegfilgrastim and Pegfilgrastim in Neutropenia, sponsored by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-07-11.
Sponsored by Hangzhou Jiuyuan Gene Engineering Co. Ltd., · Phase 1, Interventional, and Treatment
The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's planned enrollment of 24 is below the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Hangzhou Jiuyuan Gene Engineering Co. Ltd., is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pegfilgrastim
Drug: Pegfilgrastim
Drug: Pegfilgrastim
Drug: Pegfilgrastim
Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
Blood concentration of pegfilgrastim for pharmacokinetics
Time frame: 42 days
Absolute Neutrophil Count (ANC)
Time frame: 63 days
CD34+ Cell count
Time frame: 63 days
Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl
Time frame: 42 days
Safety data: including physical examinations ( include injection site reactions) , laboratory evaluations( ECGs, AST, ALT, Cr, BUN, hemostasis and coagulation test, electrolyte test ), vital signs assessments, and adverse effects (AEs).
Time frame: 63days
samples for immunogenicity
Time frame: days 21,42,63
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Hangzhou Jiuyuan Gene Engineering Co. Ltd.,