SIMpill Medication Dispensing Device in the Treatment of HCV (SIMpill HCV)

October 6, 2014 updated by: University of Chicago

Evaluation of the SIMpill Medication Dispensing Device in the Treatment of Chronic Hepatitis C

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be recruited from the outpatient/inpatient Liver GI clinic at the University of Chicago Medical Center

Description

Inclusion Criteria:

  • Patients age 18 - 70 with genotype 1 HCV
  • Compensated liver disease who are independently deemed an appropriate candidate for telaprevir containing HCV treatment regimen

Exclusion Criteria:

  • Prior liver transplantation
  • Co-infection with other types of viral hepatitis and HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
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.
Device: SIMpill device
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 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved SVR Rates
Time Frame: 2 years
To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Patient Adherence Rates
Time Frame: 2 years
To determine overall adherence rates among patients taking telaprevir
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Andrew Aronsohn, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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