Clinical Trial: Pegteograstim in Children With Solid Tumors
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
Brief Summary: To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
Detailed Summary: Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.
Sponsor: Samsung Medical Center
Current Primary Outcome:
- Rate of adverse events [ Time Frame: Up to 3 weeks after the injection of pegteograsim ]
- Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) [ Time Frame: Up to 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of severe neutropenia (ANC < 100/uL) [ Time Frame: Up to 6 weeks ]
- Lowest value of ANC [ Time Frame: Up to 6 weeks ]
- Days with neutropenic fever [ Time Frame: Up to 6 weeks ]
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: May 24, 2016
Date Started: June 2016
Date Completion:
Last Updated: May 26, 2016
Last Verified: May 2016
