<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/NCT01676688</url>
  </required_header>
  <id_info>
    <org_study_id>AlfaDom</org_study_id>
    <nct_id>NCT01676688</nct_id>
  </id_info>
  <brief_title>Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home</brief_title>
  <official_title>Safety Study of Alfalastin (Human Alpha-1 Antitrypsin, 33.33 mg/ml) Administered at Home to Patients Suffering From Severe Forms of Primary Deficiency in Alpha-1 Antitrypsin, Phenotype PIZZ or PISZ, With Pulmonary Emphysema.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratoire français de Fractionnement et de Biotechnologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratoire français de Fractionnement et de Biotechnologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at&#xD;
      home or in out-of hospital locations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non interventional, observational, longitudinal, prospective, multicenter, non comparative&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">17</enrollment>
  <condition>Alpha 1-Antitrypsin Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients above 18 y.o, suffering from severe forms of primary alpha-1 antitrypsin&#xD;
        deficiency, phenotype PiZZ or PiSZ with pulmonary emphysema, currently treated , once a&#xD;
        week, as per routine practice by ALFALASTIN® at home or in out-of-hospital location.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Participation Criteria:&#xD;
&#xD;
          -  Patients above 18 y.o,&#xD;
&#xD;
          -  suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ&#xD;
             or PiSZ with pulmonary emphysema,&#xD;
&#xD;
          -  currently treated as per routine practice, once a week, by ALFALASTIN® at home or in&#xD;
             out-of-hospital location&#xD;
&#xD;
          -  and having signed informed consent.&#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>Cuvelier Antoine, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Pneumology - CHU Rouen, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mornex Jean-François, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Pneumology - CHU Lyon, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thabut Gabriel, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Pneumology - Hôpital Bichat Paris, France</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>alpha-1 antitrypsin</keyword>
  <keyword>deficiency</keyword>
  <keyword>Alfalastin</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alpha 1-Antitrypsin Deficiency</mesh_term>
  </condition_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/NCT01676688
org study id: AlfaDom
nct id: NCT01676688
lead sponsor: 
has dmc: No
The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at
      home or in out-of hospital locations.
Non interventional, observational, longitudinal, prospective, multicenter, non comparative
      study.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cuvelier Antoine, Prof.
role: Study Director
affiliation: Pneumology - CHU Rouen, France
last name: Mornex Jean-François, Prof
role: Study Chair
affiliation: Pneumology - CHU Lyon, France
last name: Thabut Gabriel, MD
role: Study Chair
affiliation: Pneumology - Hôpital Bichat Paris, France
responsible party type: Sponsor
mesh term: Alpha 1-Antitrypsin Deficiency