Chemotherapy-induced NeutropeniaNCT04460079
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
An observational study of Chemotherapy-induced Neutropenia, run by Cinnagen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- Peg-filgrastim
- Type of treatment
- Injection or infusion
- How many people
- 654 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2016to 7 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients
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.
Read the detailed description
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.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- Peg-filgrastim
- Keywords
- Febrile neutropenia, Pegfilgrastim, Post-marketing surveillance, Chemotherapy-induced neutropenia, myelosuppressive chemotherapy
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-filgrastimDrug
Also called PegaGen®
PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The frequency of neutropenia and neutropenic fever was reported
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start29 Mar 2016
- Primary completion7 Sep 2019
- Study completion7 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arash Jenabian, Professor, Principal investigator, Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460079
- Sponsor's protocol ID
- PEGAGEN.CIN.AJ.95 (IV)
- Status last verified
- May 2020
- First submitted
- 27 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35792924
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients
- ClinicalTrials.gov ID
- NCT04460079
- Acronym / sponsor ID
- PEGAGEN.CIN.AJ.95 (IV)
- Conditions
- Chemotherapy-induced Neutropenia
- Keywords
- Febrile neutropenia, Pegfilgrastim, Post-marketing surveillance, Chemotherapy-induced neutropenia, myelosuppressive chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 7 Sep 2019 (actual)
- Study completion
- 7 Sep 2019 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peg-filgrastimAlso: PegaGen®PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy | Drug | – |
Primary outcome
Safety assessment, using incidence according to SOC and PT of AEs and SAEs
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.
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.
1 secondary outcome
Effectiveness assessment: The frequency of neutropenia and neutropenic fever
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 35792924Jenabian 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Jenabian, Professor principal investigator
Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Neutropenia, run by Cinnagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment, using incidence according to SOC and PT of AEs and SAEs (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.