<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/NCT01691235</url>
  </required_header>
  <id_info>
    <org_study_id>12-1293</org_study_id>
    <nct_id>NCT01691235</nct_id>
  </id_info>
  <brief_title>SIMpill Medication Dispensing Device in the Treatment of HCV</brief_title>
  <acronym>SIMpill HCV</acronym>
  <official_title>Evaluation of the SIMpill Medication Dispensing Device in the Treatment of Chronic Hepatitis C</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects are being asked to participate in this study because they have genotype 1 Hepatitis&#xD;
      C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,&#xD;
      and telaprevir as part of their routine care. The purpose of this study is to see if the&#xD;
      SIMpill automated pill dispensing device can help subjects take their medications at the&#xD;
      times the doctor has instructed them to take it.&#xD;
&#xD;
      The SIMpill device is an automated pill dispensing device that records a time stamp each time&#xD;
      the device is opened and a dose of medication is taken. Physicians can download this data and&#xD;
      generate a precise account of when you have taken your medication. In addition, if a dose is&#xD;
      missed, the SIMpill device can be set to automatically notify you by text message if a dose&#xD;
      is overdue. The Simpill device is a new way to keep track of when you take your HCV&#xD;
      medications and will also help remind you when you forget to take a dose. In addition, this&#xD;
      information will help your doctors understand how taking medication on time effects the&#xD;
      success of the therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patients with genotype 1 HCV who are candidates for therapy with telaprevir, pegylated&#xD;
           interferon and ribavirin will be eligible for the study.&#xD;
&#xD;
        -  All patients enrolled in this study will receive a standard of care regimen of&#xD;
           telaprevir /pegylated interferon and ribavirin. This includes medication dosages,&#xD;
           follow-up, and monitoring. The only exception will be the mode of medication dispensing.&#xD;
&#xD;
        -  Patients will be asked to bring their Simpill devices to their regularly scheduled&#xD;
           clinic visits at which time medication adherence information will be downloaded by study&#xD;
           personnel. Each visit will be a regularly scheduled standard of care visit and no&#xD;
           additional clinic visits will be needed for the patient in the Simpill study arm.&#xD;
&#xD;
        -  In the event that any patient demonstrated viral breakthrough during therapy, those&#xD;
           patients will be offered an additional blood draw to screen for viral resistance. This&#xD;
           will be important to understand if patients using the Simpill device have better&#xD;
           adherence to the medication regiment which results in lower incidence of viral&#xD;
           resistance.&#xD;
&#xD;
        -  Patients in the study arm will receive a text messages each time a dose of medication is&#xD;
           missed. This message will only go to the telephone number specified by the patient and&#xD;
           will not go to members of the study team. Patients who do not have text messaging&#xD;
           capability will not be eligible for this study.&#xD;
&#xD;
        -  The initial study will be a pilot study designed to obtain preliminary data regarding&#xD;
           the feasibility of this device. This study is powered to detect differences in viral&#xD;
           kinetics over the first 4 weeks.&#xD;
&#xD;
        -  In the event that Vertex receives FDA approval for BID dosage of telaprevir prior to&#xD;
           funding and initiation of the study, the most currently approved dosing (BID) will be&#xD;
           used instead of q8 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects enrolled due to delay in device production&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Improved SVR Rates</measure>
    <time_frame>2 years</time_frame>
    <description>To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved Patient Adherence Rates</measure>
    <time_frame>2 years</time_frame>
    <description>To determine overall adherence rates among patients taking telaprevir</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Hepatitis C Virus</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <description>Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) dispensed using the Simpill device. The study staff will have access to data from the device during therapy and will be able to give subjects feedback on adherence during the course of therapy. The study team will refill the device as the medication is needed. The device will be configured to remind a subject each time a dose is missed. Subjects in this study arm will receive a text message each time a dose of medication is missed. This message will only go to the telephone number specified by the subject and will not go to members of the study team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <description>Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) as standard of care therapy where the SIMpill device will not be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SIMpill device</intervention_name>
    <description>The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. This works through a computer chip that is housed inside of the pill dispensing device that is activated each time the pill box is opened. Physicians can download this data and generate a precise account of the patient's adherence to the medication dosing schedule. In addition, if a dose is missed, the SIMpill device can be set to automatically notify the patient by text message if a dose is overdue.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A blood draw (about 1 tablespoon) if the medication is not working for a subject. This blood&#xD;
      draw is another way for the study team to measure adherence to the therapy. This blood draw&#xD;
      will be taken only once at the time HCV in the blood return to high levels. This blood draw&#xD;
      will measure HCV resistance.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the outpatient/inpatient Liver GI clinic at the University&#xD;
        of Chicago Medical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 - 70 with genotype 1 HCV&#xD;
&#xD;
          -  Compensated liver disease who are independently deemed an appropriate candidate for&#xD;
             telaprevir containing HCV treatment regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior liver transplantation&#xD;
&#xD;
          -  Co-infection with other types of viral hepatitis and HIV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Aronsohn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SIMpill</keyword>
  <keyword>HCV</keyword>
  <keyword>Chronic Hepatitis C Virus</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>
  <!-- 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/NCT01691235
org study id: 12-1293
nct id: NCT01691235
lead sponsor: 
has dmc: No
Subjects are being asked to participate in this study because they have genotype 1 Hepatitis
      C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,
      and telaprevir as part of their routine care. The purpose of this study is to see if the
      SIMpill automated pill dispensing device can help subjects take their medications at the
      times the doctor has instructed them to take it.

      The SIMpill device is an automated pill dispensing device that records a time stamp each time
      the device is opened and a dose of medication is taken. Physicians can download this data and
      generate a precise account of when you have taken your medication. In addition, if a dose is
      missed, the SIMpill device can be set to automatically notify you by text message if a dose
      is overdue. The Simpill device is a new way to keep track of when you take your HCV
      medications and will also help remind you when you forget to take a dose. In addition, this
      information will help your doctors understand how taking medication on time effects the
      success of the therapy.
-  Patients with genotype 1 HCV who are candidates for therapy with telaprevir, pegylated
           interferon and ribavirin will be eligible for the study.

        -  All patients enrolled in this study will receive a standard of care regimen of
           telaprevir /pegylated interferon and ribavirin. This includes medication dosages,
           follow-up, and monitoring. The only exception will be the mode of medication dispensing.

        -  Patients will be asked to bring their Simpill devices to their regularly scheduled
           clinic visits at which time medication adherence information will be downloaded by study
           personnel. Each visit will be a regularly scheduled standard of care visit and no
           additional clinic visits will be needed for the patient in the Simpill study arm.

        -  In the event that any patient demonstrated viral breakthrough during therapy, those
           patients will be offered an additional blood draw to screen for viral resistance. This
           will be important to understand if patients using the Simpill device have better
           adherence to the medication regiment which results in lower incidence of viral
           resistance.

        -  Patients in the study arm will receive a text messages each time a dose of medication is
           missed. This message will only go to the telephone number specified by the patient and
           will not go to members of the study team. Patients who do not have text messaging
           capability will not be eligible for this study.

        -  The initial study will be a pilot study designed to obtain preliminary data regarding
           the feasibility of this device. This study is powered to detect differences in viral
           kinetics over the first 4 weeks.

        -  In the event that Vertex receives FDA approval for BID dosage of telaprevir prior to
           funding and initiation of the study, the most currently approved dosing (BID) will be
           used instead of q8 hours.
observational model: Cohort
time perspective: Prospective
measure: Improved SVR Rates
time frame: 2 years
description: To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates.
measure: Improved Patient Adherence Rates
time frame: 2 years
description: To determine overall adherence rates among patients taking telaprevir
arm group label: Arm 1
description: Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) dispensed using the Simpill device. The study staff will have access to data from the device during therapy and will be able to give subjects feedback on adherence during the course of therapy. The study team will refill the device as the medication is needed. The device will be configured to remind a subject each time a dose is missed. Subjects in this study arm will receive a text message each time a dose of medication is missed. This message will only go to the telephone number specified by the subject and will not go to members of the study team.
arm group label: Arm 2
description: Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) as standard of care therapy where the SIMpill device will not be used.
intervention type: Device
intervention name: SIMpill device
description: The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. This works through a computer chip that is housed inside of the pill dispensing device that is activated each time the pill box is opened. Physicians can download this data and generate a precise account of the patient's adherence to the medication dosing schedule. In addition, if a dose is missed, the SIMpill device can be set to automatically notify the patient by text message if a dose is overdue.
arm group label: Arm 1
A blood draw (about 1 tablespoon) if the medication is not working for a subject. This blood
      draw is another way for the study team to measure adherence to the therapy. This blood draw
      will be taken only once at the time HCV in the blood return to high levels. This blood draw
      will measure HCV resistance.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andrew Aronsohn, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic