An observational study in Chemotherapy-induced Neutropenia, sponsored by Cinnagen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Cinnagen · Observational
The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.
The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.
The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.
Data was gathered in two booklets, each containing information on four cycles of chemotherapy, which was filled by the designated physician. The duration of PegaGen® treatment was at the physicians' discretion based on the patient's condition.
The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.
This study was single arm and 654 subjects participated across various tumor types and regimens.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 654 is above the median of 175 across 96 observational studies indexed under Neutropenia.
Browse Neutropenia studies →Cinnagen is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.
Inclusion Criteria:
PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy
Also known as: PegaGen®
Safety assessment, using incidence according to SOC and PT of AEs and SAEs
Safety evaluation was reported using summary statistics. For each AE, data was summarized using incidence according to system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done and its results was reported by frequency and percentage.
Time frame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.
Effectiveness assessment: The frequency of neutropenia and neutropenic fever
The frequency of neutropenia and neutropenic fever was reported
Time frame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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