Clinical trial NCT01691235: SIMpill Medication Dispensing Device in the Treatment of HCV
Official title: Evaluation of the SIMpill Medication Dispensing Device in the Treatment of Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Hepatitis C Virus
Keywords: SIMpill
HCV
Chronic Hepatitis C Virus
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the outpatient/inpatient Liver GI clinic at the University of Chicago Medical Center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved SVR Rates
timeFrame: 2 years
Secondary outcomes:
measure: Improved Patient Adherence Rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrew Aronsohn, MD
role: PRINCIPAL_INVESTIGATOR
References: