Clinical Trial: Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients
Brief Summary: The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.
Detailed Summary:
Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Current Primary Outcome: Blood concentration of pegfilgrastim for pharmacokinetics [ Time Frame: 42 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Dates:
Date Received: July 2, 2012
Date Started: February 2012
Date Completion: June 2013
Last Updated: July 10, 2012
Last Verified: July 2012
