<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03303599</url>
  </required_header>
  <id_info>
    <org_study_id>P17-094</org_study_id>
    <nct_id>NCT03303599</nct_id>
  </id_info>
  <brief_title>Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6</brief_title>
  <official_title>Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus&#xD;
      pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC)&#xD;
      viral infection has been shown to be safe and effective in randomized controlled clinical&#xD;
      trials.&#xD;
&#xD;
      This observational study is an effectiveness research examining the regimen of GLE/PIB, used&#xD;
      according to local label, under real world conditions in a clinical practice patient&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Actual">January 24, 2020</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>
  <primary_outcome>
    <measure>Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)</measure>
    <time_frame>12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir</time_frame>
    <description>SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Taking Concomitant Medications</measure>
    <time_frame>Up to approximately 28 weeks</time_frame>
    <description>The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed</measure>
    <time_frame>Up to approximately 16 weeks</time_frame>
    <description>The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease [MDRD] equation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Healthcare Resource Utilization (HCRU)</measure>
    <time_frame>Up to approximately 28 weeks</time_frame>
    <description>Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call) with an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Using Each Treatment Regimen</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Co-morbidities</measure>
    <time_frame>Baseline (Day 1)</time_frame>
    <description>The percentage of participants with co-morbidities at baseline.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2118</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>HCV Genotypes 1, 2, 3, 4, 5, or 6 participants</arm_group_label>
    <description>Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving GLE/PIB who have started the treatment combination recommended in the&#xD;
        current local label for their disease characteristics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are treatment-naïve or treatment-experienced with pegylatedinterferon&#xD;
             (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed&#xD;
             chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated&#xD;
             cirrhosis, receiving combination therapy with the all oral glecaprevir plus&#xD;
             pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines&#xD;
             and in line with the current local label.&#xD;
&#xD;
          -  Participants may be enrolled up to 4 weeks after treatment initiation&#xD;
&#xD;
          -  Participants must not be participating or intending to participate in a concurrent&#xD;
             interventional therapeutic trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931</name>
      <address>
        <city>Klagenfurt Am Woerthersee</city>
        <state>Kaernten</state>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital St. Polten /ID# 169918</name>
      <address>
        <city>St. Pölten</city>
        <state>Niederoesterreich</state>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KH der Elisabethinen Linz GmbH /ID# 169915</name>
      <address>
        <city>Linz</city>
        <state>Oberoesterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Graz /ID# 169932</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Hall /ID# 169930</name>
      <address>
        <city>Hall in Tirol</city>
        <state>Tirol</state>
        <zip>6060</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus /ID# 169922</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels - Grieskirchen /ID# 169916</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital der Stadt Wien /ID# 169914</name>
      <address>
        <city>Wien</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uza /Id# 170960</name>
      <address>
        <city>Edegem</city>
        <state>Antwerpen</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc /ID# 170964</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <state>Bruxelles-Capitale</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Stedelijk Ziekenhuis /ID# 170876</name>
      <address>
        <city>Aalst</city>
        <state>Oost-Vlaanderen</state>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent /ID# 170922</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Leuven /ID# 170921</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Wallonie Picarde /ID# 200822</name>
      <address>
        <city>Tournai</city>
        <state>Wallonne, Region</state>
        <zip>7500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zna /Id# 170927</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Pierre /ID# 170920</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Erasme /ID# 170918</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brugmann /ID# 170956</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Z.O.L - Campus St. Jan /ID# 171058</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Middelares Gent /ID# 170874</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis /ID# 170958</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge /ID# 170931</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC Liege /ID# 170926</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Pare /ID# 171107</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Edith Cavell /ID# 170932</name>
      <address>
        <city>Uccle</city>
        <zip>1180</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dinant Godinne /ID# 170929</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Orleans - Hopital de la Source /ID# 202360</name>
      <address>
        <city>Orleans CEDEX 2</city>
        <state>Centre-Val De Loire</state>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Georges Renon /ID# 202737</name>
      <address>
        <city>Niort CEDEX</city>
        <state>Deux-Sevres</state>
        <zip>79028</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Besancon - Jean Minjoz /ID# 208502</name>
      <address>
        <city>Besancon</city>
        <state>Doubs</state>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dupuytren /ID# 202514</name>
      <address>
        <city>Limoges CEDEX 1</city>
        <state>Franche-Comte</state>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Haut-Lévêque /ID# 202501</name>
      <address>
        <city>Pessac CEDEX</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Purpan /ID# 202357</name>
      <address>
        <city>TOULOUSE Cedex 9</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Purpan /ID# 204201</name>
      <address>
        <city>TOULOUSE Cedex 9</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Annecy Genevois Site Annecy /ID# 202804</name>
      <address>
        <city>Epagny Metz Tessy</city>
        <state>Haute-Savoie</state>
        <zip>74370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Spécialisé Esquirol /ID# 204522</name>
      <address>
        <city>Limoges</city>
        <state>Haute-Vienne</state>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Béziers /ID# 202948</name>
      <address>
        <city>Beziers CEDEX</city>
        <state>Herault</state>
        <zip>34525</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Eloi /ID# 202512</name>
      <address>
        <city>Montpellier CEDEX 5</city>
        <state>Herault</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon /ID# 202675</name>
      <address>
        <city>Clichy</city>
        <state>Ile-de-France</state>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Broussais /ID# 202677</name>
      <address>
        <city>St Malo CEDEX</city>
        <state>Ille-et-Vilaine</state>
        <zip>35403</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU NANCY - Hopital Brabois Adultes /ID# 202570</name>
      <address>
        <city>Vandoeuvre les Nancy CEDEX</city>
        <state>Meurthe-et-Moselle</state>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Timone /ID# 202792</name>
      <address>
        <city>Marseille CEDEX 05</city>
        <state>Provence-Alpes-Cote-d Azur</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles Nicolle CHU Rouen /ID# 203518</name>
      <address>
        <city>Rouen CEDEX</city>
        <state>Seine-Maritime</state>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hosp Intercommunal de Creteil /ID# 202566</name>
      <address>
        <city>Creteil</city>
        <state>Val-de-Marne</state>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet medical /ID# 202794</name>
      <address>
        <city>Aix En Provence</city>
        <zip>13100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers /ID# 202500</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique du Tondu /ID# 207508</name>
      <address>
        <city>Bordeaux</city>
        <zip>33082</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Endo Nord Isere /ID# 204181</name>
      <address>
        <city>Bourgoin Jallieu</city>
        <zip>38300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Cavale Blanche /ID# 202640</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Antoine Beclere /ID# 202676</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Estaing /ID# 202949</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor /ID# 202806</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Hyeres /ID# 202515</name>
      <address>
        <city>Hyeres</city>
        <zip>83407</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Cuissard, Le Port, FR /ID# 203487</name>
      <address>
        <city>Le Port</city>
        <zip>97420</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. de Bretagne Sud /ID# 202362</name>
      <address>
        <city>Lorient</city>
        <zip>56322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Croix Rousse /ID# 203071</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Edouard Herriot /ID# 203149</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen /ID# 205073</name>
      <address>
        <city>Marseille</city>
        <zip>13003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Joseph /ID# 202519</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Medical, Boyer Darrigr /ID# 202050</name>
      <address>
        <city>Nanterre</city>
        <zip>92000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital l'Archet 2 /ID# 205295</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes /ID# 208200</name>
      <address>
        <city>Nimes Cedex 9</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Antoine /ID# 202565</name>
      <address>
        <city>Paris Cedex 12</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Bichat-Claude Bernard /ID# 202513</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pitie Salpetriere /ID# 202364</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier PERPIGNAN /ID# 205762</name>
      <address>
        <city>Perpignan</city>
        <zip>66000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Robert Debre /ID# 202953</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Arnault Tzanck /ID# 202363</name>
      <address>
        <city>Saint Laurent Du Var</city>
        <zip>06721</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrodoc /Id# 206290</name>
      <address>
        <city>St Jean de Vedas</city>
        <zip>34430</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Medical, Dr. Constant, /ID# 202361</name>
      <address>
        <city>Toulon</city>
        <zip>83000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Amroise Pare /ID# 205064</name>
      <address>
        <city>Toulouse</city>
        <zip>31082</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Joseph Ducuing /ID# 205666</name>
      <address>
        <city>Toulouse</city>
        <zip>81059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ctre Hospitalier de Tourcoing /ID# 202358</name>
      <address>
        <city>Tourcoing</city>
        <zip>59208</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ctre Hospitalier de Tourcoing /ID# 202805</name>
      <address>
        <city>Tourcoing</city>
        <zip>59208</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Paul Brousse /ID# 202623</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Laiko /ID# 206421</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419</name>
      <address>
        <city>Kifissia</city>
        <state>Attiki</state>
        <zip>14564</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tzaneio general hospital of Piraeus /ID# 208828</name>
      <address>
        <city>Piraeus</city>
        <state>Attiki</state>
        <zip>18536</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papageorgiou General Hospital Thessaloniki /ID# 207980</name>
      <address>
        <city>Nea Efkarpia</city>
        <state>Thessaloniki</state>
        <zip>54603</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen Univ Hosp Alexandroupolis /ID# 206416</name>
      <address>
        <city>Alexandroupolis</city>
        <zip>68100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420</name>
      <address>
        <city>Pireaus</city>
        <zip>18454</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinic Thessaloniki /ID# 207981</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54622</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Gen Hosp AHEPA /ID# 209961</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54636</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interbalkan Medical Center /ID# 206417</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57001</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center /ID# 169321</name>
      <address>
        <city>Be'er Sheva</city>
        <state>HaDarom</state>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HaEmek Medical Center /ID# 169318</name>
      <address>
        <city>Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center /ID# 169370</name>
      <address>
        <city>Be'er Ya'akov</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maccabi Health Services /ID# 169372</name>
      <address>
        <city>Gush Dan</city>
        <zip>7565016</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center /ID# 169368</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center /ID# 169316</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion Medical Center /ID# 169358</name>
      <address>
        <city>Haifa</city>
        <zip>3339419</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center /ID# 169309</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center /ID# 169329</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Institute, Division of Medicine /ID# 169360</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center /ID# 169327</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galilee Medical Center /ID# 169325</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center /ID# 169320</name>
      <address>
        <city>Petakh Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center /ID# 169365</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5239424</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Medical Center /ID# 169313</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Federico II /ID# 168131</name>
      <address>
        <city>Naples</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sant Orsola Malpighi /ID# 168127</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711</name>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda /ID# 168138</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda /ID# 168712</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137</name>
      <address>
        <city>Milan</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Citta della Salute Scienza /ID# 168142</name>
      <address>
        <city>Turin</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione PTV Policlinico Tor Vergata /ID# 168709</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università Cattolica Sacro Cuore /ID# 168781</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Paolo Giaccone /Id# 168134</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Universitaria Ospedali /ID# 168129</name>
      <address>
        <city>Bari</city>
        <zip>70120</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU di Cagliari - Presidio di /ID# 168132</name>
      <address>
        <city>Cagliari</city>
        <zip>09042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U Sant'Anna di Ferrara /ID# 168714</name>
      <address>
        <city>Ferrara</city>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Riuniti di Foggia /ID# 168143</name>
      <address>
        <city>Foggia</city>
        <zip>71121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale SM Goretti /ID# 169257</name>
      <address>
        <city>Latina</city>
        <zip>04100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico G. Martino /ID# 168139</name>
      <address>
        <city>Messina</city>
        <zip>98125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Carlo Borromeo /ID# 168144</name>
      <address>
        <city>Milan</city>
        <zip>20153</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Luigi Sacc /ID# 168136</name>
      <address>
        <city>Milan</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Luigi Sacc /ID# 168140</name>
      <address>
        <city>Milan</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Rilievo /ID# 168141</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO Domenico Cutugno /ID# 168133</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi della /ID# 168135</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Maggiore d /ID# 168710</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova /ID# 168125</name>
      <address>
        <city>Padua</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova /ID# 168126</name>
      <address>
        <city>Padua</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero - Universi /ID# 168130</name>
      <address>
        <city>Pisa</city>
        <zip>56125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Lazzaro Spallanzani /ID# 169234</name>
      <address>
        <city>Rome</city>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU OO. RR. San Giovanni di Di /ID# 168715</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862</name>
      <address>
        <city>Walbrzych</city>
        <state>Dolnoslaskie</state>
        <zip>58-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449</name>
      <address>
        <city>Zielona Gora</city>
        <state>Dolnoslaskie</state>
        <zip>65-191</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Przychodnia Specjalistycz /ID# 208334</name>
      <address>
        <city>Zychlin</city>
        <state>Lodzkie</state>
        <zip>31-956</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Wojewodzki w Opolu /ID# 208444</name>
      <address>
        <city>Opole</city>
        <state>Opolskie</state>
        <zip>46-020</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604</name>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny W Chorzowie /Id# 209129</name>
      <address>
        <city>Chorzow</city>
        <state>Slaskie</state>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ All-Medicus /ID# 208452</name>
      <address>
        <city>Katowice</city>
        <state>Slaskie</state>
        <zip>40-659</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ID Clinic /ID# 208332</name>
      <address>
        <city>Myslowice</city>
        <state>Slaskie</state>
        <zip>41-406</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Obserwacyjn /ID# 209345</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-030</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Szpital Zespolony w Kielcach /ID# 210569</name>
      <address>
        <city>Kielce</city>
        <zip>25-736</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpit Bieganskiego /ID# 208445</name>
      <address>
        <city>Lodz</city>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpit Bieganskiego /ID# 209608</name>
      <address>
        <city>Lodz</city>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MED-FIX Centrum Medyczne Sp. z /ID# 208453</name>
      <address>
        <city>Warsaw</city>
        <zip>53-522</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Barreiro Montijo, EPE /ID# 211267</name>
      <address>
        <city>Barreiro</city>
        <state>Lisboa</state>
        <zip>2834-003</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195</name>
      <address>
        <city>Vila Nova De Gaia</city>
        <state>Porto</state>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Garcia de Orta, E.P.E /ID# 207717</name>
      <address>
        <city>Almada</city>
        <state>Setubal</state>
        <zip>2805-267</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463</name>
      <address>
        <city>Lisboa</city>
        <zip>1069-166</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto EPE /ID# 207733</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Geneve /ID# 203435</name>
      <address>
        <city>Genève</city>
        <state>Geneve</state>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen /ID# 201025</name>
      <address>
        <city>St. Gallen</city>
        <state>Sankt Gallen</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital, Universitaetsklinik /ID# 201022</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Epatocentro Ticino /ID# 201024</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Neuchatelois /ID# 201026</name>
      <address>
        <city>Neuchatel</city>
        <zip>CH-2000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Zuerich /ID# 201023</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Sustained Virological Response</keyword>
  <keyword>Chronic Hepatitis C genotype 1</keyword>
  <keyword>Chronic Hepatitis C genotype 2</keyword>
  <keyword>Chronic Hepatitis C genotype 3</keyword>
  <keyword>Chronic Hepatitis C genotype 4</keyword>
  <keyword>Chronic Hepatitis C genotype 5</keyword>
  <keyword>Chronic Hepatitis C genotype 6</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_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/NCT03303599
org study id: P17-094
nct id: NCT03303599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus
      pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC)
      viral infection has been shown to be safe and effective in randomized controlled clinical
      trials.

      This observational study is an effectiveness research examining the regimen of GLE/PIB, used
      according to local label, under real world conditions in a clinical practice patient
      population.
observational model: Cohort
time perspective: Prospective
measure: Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
time frame: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir
description: SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir
measure: Percentage of Participants Taking Concomitant Medications
time frame: Up to approximately 28 weeks
description: The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.
measure: Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed
time frame: Up to approximately 16 weeks
description: The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).
measure: Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)
time frame: Up to 16 weeks
description: Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease [MDRD] equation).
measure: Number of Healthcare Resource Utilization (HCRU)
time frame: Up to approximately 28 weeks
description: Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call) with an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.
measure: Percentage of Participants Using Each Treatment Regimen
time frame: Up to 16 weeks
description: Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)
measure: Percentage of Participants with Co-morbidities
time frame: Baseline (Day 1)
description: The percentage of participants with co-morbidities at baseline.
arm group label: HCV Genotypes 1, 2, 3, 4, 5, or 6 participants
description: Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Austria
country: Belgium
country: France
country: Greece
country: Israel
country: Italy
country: Poland
country: Portugal
country: Switzerland
url: http://rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
sharing ipd: Undecided