<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04460079</url>
  </required_header>
  <id_info>
    <org_study_id>PEGAGEN.CIN.AJ.95 (IV)</org_study_id>
    <nct_id>NCT04460079</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN</brief_title>
  <official_title>Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cinnagen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cinnagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study was an observational, multicenter, non-interventional, single arm, open&#xD;
      label, PMS study conducted in Iran.&#xD;
&#xD;
      The primary objective of this study was safety assessment, including the rate of AEs. The&#xD;
      secondary objective was the effectiveness evaluation in the prevention of&#xD;
      chemotherapy-induced FN.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study was an observational, multicenter, non-interventional, single arm, open&#xD;
      label, PMS study conducted in Iran.&#xD;
&#xD;
      Data was gathered in two booklets, each containing information on four cycles of&#xD;
      chemotherapy, which was filled by the designated physician. The duration of PegaGen®&#xD;
      treatment was at the physicians' discretion based on the patient's condition.&#xD;
&#xD;
      The primary objective of this study was safety assessment, including the rate of AEs. The&#xD;
      secondary objective was the effectiveness evaluation in the prevention of&#xD;
      chemotherapy-induced FN.&#xD;
&#xD;
      This study was single arm and 654 subjects participated across various tumor types and&#xD;
      regimens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2016</start_date>
  <completion_date type="Actual">September 7, 2019</completion_date>
  <primary_completion_date type="Actual">September 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety assessment, using incidence according to SOC and PT of AEs and SAEs</measure>
    <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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness assessment: The frequency of neutropenia and neutropenic fever</measure>
    <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.</time_frame>
    <description>The frequency of neutropenia and neutropenic fever was reported</description>
  </secondary_outcome>
  <enrollment type="Actual">654</enrollment>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peg-filgrastim</intervention_name>
    <description>PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy</description>
    <other_name>PegaGen®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving various tumor types and regimens with chemotherapy regimens of high FN&#xD;
        risk, will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years,&#xD;
&#xD;
          -  with the diagnosis of various types of cancers (such as lymphoma, breast, lung,&#xD;
             testicular, prostate, ovary and gastrointestinal cancers), receiving first-line&#xD;
             chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician&#xD;
             decision.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arash Jenabian, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oncology &amp; Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 5, 2020</last_update_submitted>
  <last_update_submitted_qc>July 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Febrile neutropenia</keyword>
  <keyword>Pegfilgrastim</keyword>
  <keyword>Post-marketing surveillance</keyword>
  <keyword>Chemotherapy-induced neutropenia</keyword>
  <keyword>myelosuppressive chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04460079
org study id: PEGAGEN.CIN.AJ.95 (IV)
nct id: NCT04460079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
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.
description: 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.
measure: 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.
description: The frequency of neutropenia and neutropenic fever was reported
intervention type: Drug
intervention name: Peg-filgrastim
description: PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy
other name: PegaGen®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arash Jenabian, Professor
role: Principal Investigator
affiliation: Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran
responsible party type: Sponsor
mesh term: Neutropenia
mesh term: Febrile Neutropenia
mesh term: Lenograstim
sharing ipd: Undecided