Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
1 other identifier
observational
654
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2019
CompletedFirst Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedJuly 7, 2020
May 1, 2020
3.4 years
June 27, 2020
July 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Secondary Outcomes (1)
Effectiveness assessment: The frequency of neutropenia and neutropenic fever
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.
Interventions
PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy
Eligibility Criteria
Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.
You may qualify if:
- Patients aged ≥18 years,
- with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician decision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cinnagenlead
Related Publications (1)
Jenabian A, Ehsanpour A, Mortazavizadeh SMR, Raafat J, Razavi M, Khosravi A, Seifi S, Salimi B, Anjidani N, Kafi H. Evaluating the safety and effectiveness of PegaGen(R) (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study. Support Care Cancer. 2022 Oct;30(10):8151-8158. doi: 10.1007/s00520-022-07265-2. Epub 2022 Jul 6.
PMID: 35792924DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arash Jenabian, Professor
Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 7, 2020
Study Start
March 29, 2016
Primary Completion
September 7, 2019
Study Completion
September 7, 2019
Last Updated
July 7, 2020
Record last verified: 2020-05