<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/NCT01713309</url>
  </required_header>
  <id_info>
    <org_study_id>HBP01</org_study_id>
    <nct_id>NCT01713309</nct_id>
  </id_info>
  <brief_title>Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim)</brief_title>
  <acronym>HBP-Neupogen</acronym>
  <official_title>Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Swedish Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically&#xD;
      ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a&#xD;
      prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients&#xD;
      with acute respiratory failure requiring intubation. In this substudy, the investigators&#xD;
      evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1996</start_date>
  <completion_date type="Actual">September 1998</completion_date>
  <primary_completion_date type="Actual">June 1998</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>up to 28 days</time_frame>
    <description>the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>follow up measures</measure>
    <time_frame>Up to day 90</time_frame>
    <description>frequency of nosocomial infections, length of mechanical ventilatory support, length of stay in the ICU, 28-day mortality rate, 90-day mortality rate, and laboratory values for neutrophil count</description>
  </secondary_outcome>
  <other_outcome>
    <measure>inflammatory mediators</measure>
    <time_frame>up to day 7</time_frame>
    <description>cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>Filgrastim</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Filgrastim 300 microgr/day subcutaneously for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NaCl 0.9%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Corresponding placebo once daily, subcutaneously for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Filgrastim</intervention_name>
    <description>Filgrastim 300 ug daily for 7 days, subcutaneously.</description>
    <arm_group_label>Filgrastim</arm_group_label>
    <other_name>Neupogen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria for original study. For the substudy, all these patients were included.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Admitted to the ICU no longer than 12 hrs before study entry&#xD;
&#xD;
          -  Intubated because of ventilation insufficiency no longer than 48 hrs before study&#xD;
             entry&#xD;
&#xD;
          -  Clinically expected stay in the ICU &gt; 48 hrs&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Total leukocyte count of &gt; 50,000/mm3&#xD;
&#xD;
          -  Administration of filgrastim, sargramostim, or other biological response modifiers&#xD;
             within 7 days before study entry&#xD;
&#xD;
          -  Known hypersensitivity or allergic reaction to Escherichia coli-derived products&#xD;
&#xD;
          -  Participation in another drug study&#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>Ville Pettila, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsi-Maija Kaukonen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <results_reference>
    <citation>Pettila V, Takkunen O, Varpula T, Markkola A, Porkka K, Valtonen V. Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: interim analysis of a prospective, placebo-controlled, double-blind study. Crit Care Med. 2000 Nov;28(11):3620-5. doi: 10.1097/00003246-200011000-00011.</citation>
    <PMID>11098963</PMID>
  </results_reference>
  <results_reference>
    <citation>Takala A, Pettila V, Takkunen O, Rintala E, Kautiainen H, Repo H. Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients. Inflamm Res. 2005 Apr;54(4):180-5. doi: 10.1007/s00011-005-1340-2.</citation>
    <PMID>15883741</PMID>
  </results_reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Kirsi-Maija Kaukonen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Filgrastim</keyword>
  <keyword>G-CSF</keyword>
  <keyword>Heparin-binding protein</keyword>
  <keyword>critically ill</keyword>
  <keyword>acute respiratory failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01713309
org study id: HBP01
nct id: NCT01713309
lead sponsor: 
collaborator: 
has dmc: No
This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically
      ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a
      prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients
      with acute respiratory failure requiring intubation. In this substudy, the investigators
      evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of adverse events
time frame: up to 28 days
description: the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7.
measure: follow up measures
time frame: Up to day 90
description: frequency of nosocomial infections, length of mechanical ventilatory support, length of stay in the ICU, 28-day mortality rate, 90-day mortality rate, and laboratory values for neutrophil count
measure: inflammatory mediators
time frame: up to day 7
description: cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein)
arm group label: Filgrastim
arm group type: Active Comparator
description: Filgrastim 300 microgr/day subcutaneously for 7 days
arm group label: NaCl 0.9%
arm group type: Placebo Comparator
description: Corresponding placebo once daily, subcutaneously for 7 days
intervention type: Drug
intervention name: Filgrastim
description: Filgrastim 300 ug daily for 7 days, subcutaneously.
arm group label: Filgrastim
other name: Neupogen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ville Pettila, MD, PhD
role: Study Director
affiliation: Helsinki University Central Hospital
last name: Kirsi-Maija Kaukonen, MD, PhD
role: Principal Investigator
affiliation: Helsinki University Central Hospital
facility: 
country: Finland
citation: Pettila V, Takkunen O, Varpula T, Markkola A, Porkka K, Valtonen V. Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: interim analysis of a prospective, placebo-controlled, double-blind study. Crit Care Med. 2000 Nov;28(11):3620-5. doi: 10.1097/00003246-200011000-00011.
PMID: 11098963
citation: Takala A, Pettila V, Takkunen O, Rintala E, Kautiainen H, Repo H. Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients. Inflamm Res. 2005 Apr;54(4):180-5. doi: 10.1007/s00011-005-1340-2.
PMID: 15883741
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Kirsi-Maija Kaukonen
investigator title: MD, PhD
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
mesh term: Critical Illness
mesh term: Lenograstim