SIMpill Medication Dispensing Device in the Treatment of HCV

Withdrawn

• Conditions: Chronic Hepatitis C Virus
• Interventions: Device: SIMpill device

• Registration Number: NCT01691235
• Lead Sponsor: University of Chicago

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	SIMpill device	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.

Primary Outcome Measures

Name	Time	Method
Improved SVR Rates	2 years	To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates.

Secondary Outcome Measures

Name	Time	Method
Improved Patient Adherence Rates	2 years	To determine overall adherence rates among patients taking telaprevir

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States