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Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence (DASH)

2018年12月12日 更新者：Proteus Digital Health, Inc.

Evaluation of Wirelessly Observed Therapy to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence to Treatment

This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their hepatitis therapy. In this single-arm, prospective study, subjects at high risk for nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the providers will have access to the ingestion adherence.

研究概览

地位

未知

条件

干预/治疗

详细说明

Hepatitis C virus (HCV) is a preventable and curable blood-borne virus. Adherence to HCV therapies is essential to achieve sustained virologic response (SVR) or cure. New direct-acting agents (DAA) are now available, such as fixed-dose combination of ledipasvir and sofosbuvir, which is given once daily with or without ribavirin to treat HCV infection in 8-12 weeks, which can cure hepatitis C with a once daily regimen.

which is given once daily with or without ribavirin to treat HCV infection in 8-12 weeks.

Providers and third-party payers are concerned that patients use these high-cost therapies as prescribed and obtain the intended value of their treatment, so as to prevent otherwise avoidable medicine wastage and re-treatment. Some HCV-infected patients are currently excluded from using the newer direct-acting therapies because they are considered to have a high risk of not completing their intended treatment, or they do not have access to care due to other issues like transportation difficulties.

Additionally, third party payers and providers have proposed to assess patient adherence during treatment with HCV RNA level and additional adherence assessments. However, determining adherence to anti-viral therapy based upon decreases that are observed in RNA titers at intermittent intervals, or periodic assessments of medication use, subsequent to therapy initiation are indirect and retrospective. Additionally, this practice can be a burden for patients, especially those who live far away from their providers.

Proteus Discover™ provides wirelessly observed therapy (WOT) for passive direct, timely confirmation of medication ingestion. Proteus Discover includes a FDA cleared and CE-marked device, which consists of three components: 1) an Ingestible Sensor (IS) embedded inside of a placebo pill, which can be co-encapsulated with prescribed medication (CEM); 2) a wearable sensor patch (herein referred to as the Proteus Patch), which passively detects and stores time-stamped CEM ingestions, as well as physiological and behavioral metrics such as heart rate and activity patterns (e.g., step count, time spent in physical activity, number of hours of rest); and 3) software to aggregate and display Proteus Patch data. The offering also includes the Proteus Discover App, which allows the subject to review and interact with the data via a mobile device. Providers can view the data via the Proteus Discover Portal.

To provide WOT in this study, the Proteus Ingestible Sensor pill will be placed in a capsule along with HCV medication by the patient's pharmacy to create a digital medicine version of the therapy. The adhesive wearable sensor patch worn by the patient on the left lower torso will be used for detection of CEM ingestions which are then displayed on a mobile application for the patient, and on a web portal for physicians and the study healthcare teams to assist them in identifying when support for the subject may be needed for taking medication consistently.

研究类型

介入性

注册 (预期的)

253

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University Of Alabama
    • California
      • San Francisco、California、美国、94110
        • Zuckerberg San Francisco General Hospital
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • Peak Gastroenterology Associates
      • Denver、Colorado、美国、80204
        • Denver Health
    • District of Columbia
      • Washington、District of Columbia、美国、20017
        • Providence Health System
    • Florida
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center
      • Tampa、Florida、美国、33612
        • Apex Clinical Research
    • Illinois
      • Chicago、Illinois、美国、60637
        • The Ruth M. Rothstein CORE Center
    • Maryland
      • Baltimore、Maryland、美国、21205
        • Johns Hopkins University
    • Massachusetts
      • Springfield、Massachusetts、美国、01105
        • The Research Institute
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Health System
      • Detroit、Michigan、美国、48201
        • Harper University Hospital
    • New Mexico
      • Santa Fe、New Mexico、美国、87502
        • Southwest CARE Center
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
    • Washington
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
    • Wisconsin
      • Madison、Wisconsin、美国、53713
        • SSM Health Dean Medical Group

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Participants must have insurance or other method (e.g. patient assistance program) to pay for medicine.

Inclusion Criteria:

  • A subject must meet ALL of the following criteria to be considered for enrollment into this study:

    1. Adults (≥18 years old) who are diagnosed with hepatitis C deemed chronic by the investigator
    2. Candidate for treatment for oral direct acting agent for hepatitis C such as fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir with insurance coverage for therapy. Subjects may take other medicines that will not be co-encapsulated (e.g. ribavirin)

    3. One of more of the following risk factors for nonadherence:

      1. Active alcohol or substance abuse (positive urine drug screen, illicit use in past 3 months, and/or in opioid substitution program), OR
      2. Patient reported history of hospitalization within past 2 years for a psychiatric comorbidity, OR
      3. Evidence of nonadherence to medications (e.g. self-report or refill history indicative of nonadherence), OR
      4. History of at least one missed clinic visit for hepatitis management, OR
      5. Patient-reported history of one or more transportation barriers (e.g. burden due to time and/or distance or lack of access to regular transportation) to healthcare access, which creates a risk for missed or delayed care
    4. Study subject has daily access to a telephone for communicating with the study personnel and study personnel contacting the study subject
    5. Ability to read and understand the instructions for the study.
    6. Willingness to adhere to all study procedures (both onsite and offsite), including troubleshooting of the product by a third-party, if needed.
    7. Capacity to and willing to provide informed consent. All subjects must have a signed informed consent document prior to participating in this study
    8. Currently owns and uses a smart phone or tablet, or has capacity to learn use of study mobile device as determined by investigator.

    9. Adequate data connectivity at home via cellular service and/or access to a secure wireless internet (WiFi) network with the proficiency to connect a mobile device to the WiFi network.

      • Note: None of the five individual sub-criteria (i.e., 3a, 3b, 3c, 3d, or 3e) alone may be used to qualify more than approximately 20% of the total study population for randomization. For example, "3d" may be used to qualify no more than 20% of the study population for randomization without an additional sub-criteria also being met (e.g., "3d" + "3a"). The data center will monitor the use of these five enrolment sub-criteria, and study sites will be notified when qualification for enrollment may no longer be based upon meeting only a specific one of the five sub-criteria alone (e.g., "3d" alone).

Exclusion Criteria:

  • ANY 1 of the following will exclude a subject from being enrolled into the study:

    1. BMI > 40 kg/m2 2. Active skin infection or active dermatitis, OR history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis) 3. Allergy to adhesive bandages/tapes (e.g. Band-Aids®) 4. Severely decompensated cirrhosis (Child-Pugh C) or a liver transplant candidate 5. Any condition that in the investigator's opinion could preclude safe participation in the study (e.g. contraindication to hepatitis C therapy) or would preclude the subject from being able to participate in the study protocol requirements 6. Participating in a drug study or medical device clinical study (including its safety follow-up period as defined by protocol) 30 days prior to study start or completion 7. Unwilling to take a gelatin capsule because it is manufactured from animal origins (e.g. for religious reasons) 8. Allergy to food dye 10. Terminal illness (≤ 1 year of life anticipated). 10. Currently known to be pregnant or nursing an infant. 11. For women of childbearing potential, not using an acceptable form of contraception for at least 2 months prior to screening and throughout the duration of the study. Accepted means of contraception include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy.

    12. Positive pregnancy test during screening 13. Inability to swallow the test capsule

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Digital Medicine Arm
Subjects enrolled in this single arm study will be directed to use digital medicine versions of their hepatitis C therapy for the duration of therapy.
设备：Digital Medicine
The subjects in the study will be monitored using the Proteus Discover offering. Subjects will use Proteus Discover plus a digital version of HCV therapy (IS co-encapsulated with fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir; or fixed-dose sofosbuvir, velpatasvir, and voxilaprevir). The subject's prescribed HCV medication will be co-encapsulated with the Proteus Ingestible Sensor pill by an appropriately licensed and qualified pharmacy as per a licensed health care provider's order (prescription).

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
SVR12 Rate
大体时间：12 weeks following completion of their hepatitis C therapy
Proportion of subjects achieving sustained viral response, 12 weeks following completion of their hepatitis C therapy
12 weeks following completion of their hepatitis C therapy

次要结果测量

结果测量
措施说明
大体时间
SVR4 Rate
大体时间：4 weeks following completion of their hepatitis C therapy
Proportion of subjects achieving sustained viral response, 4 weeks following completion of their hepatitis C therapy
4 weeks following completion of their hepatitis C therapy
Ingestion Adherence
大体时间：8 to 16 weeks (during therapy)
Mean ingestion adherence to the primary hepatitis C therapy measured by the digital medicine offering
8 to 16 weeks (during therapy)
Safety Profile:Summary details of all adverse events during the study
大体时间：Up to 24 weeks
Summary details of all adverse events during the study
Up to 24 weeks
Subject Satisfaction
大体时间：4 weeks following completion of their hepatitis C therapy
Feedback from subjects during the study via a survey form
4 weeks following completion of their hepatitis C therapy

其他结果措施

结果测量
措施说明
大体时间
Treatment efficiency
大体时间：Up to 24 weeks
Number of clinic and lab visits and other resources used during the study
Up to 24 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Proteus Digital Health, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年7月21日

初级完成 (预期的)

2019年4月30日

研究完成 (预期的)

2019年4月30日

研究注册日期

首次提交

2017年5月22日

首先提交符合 QC 标准的

2017年5月23日

首次发布 (实际的)

2017年5月24日

研究记录更新

最后更新发布 (实际的)

2018年12月13日

上次提交的符合 QC 标准的更新

2018年12月12日

最后验证

2018年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PB-WOTFORHEPC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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膳食补充剂

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