SIMpill Medication Dispensing Device in the Treatment of HCV (SIMpill HCV)
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.
研究概览
详细说明
- 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.
研究类型
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60637
- The University of Chicago
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improved SVR Rates
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improved Patient Adherence Rates
大体时间：2 years
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To determine overall adherence rates among patients taking telaprevir
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2 years
|
合作者和调查者
调查人员
- 首席研究员：Andrew Aronsohn, MD、University of Chicago
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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