SIMpill Medication Dispensing Device in the Treatment of HCV (SIMpill HCV)
6 oktober 2014 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
- 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.
Studietyp
Observationell
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
- The University of Chicago
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Subjects will be recruited from the outpatient/inpatient Liver GI clinic at the University of Chicago Medical Center
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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.
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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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Improved SVR Rates
Tidsram: 2 years
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To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates.
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2 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Improved Patient Adherence Rates
Tidsram: 2 years
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To determine overall adherence rates among patients taking telaprevir
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2 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Andrew Aronsohn, MD, University of Chicago
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2012
Primärt slutförande (Faktisk)
1 januari 2013
Avslutad studie (Faktisk)
1 januari 2013
Studieregistreringsdatum
Först inskickad
17 september 2012
Först inskickad som uppfyllde QC-kriterierna
19 september 2012
Första postat (Uppskatta)
24 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 oktober 2014
Senast verifierad
1 oktober 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-1293
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .