Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence (DASH)
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|ClinicalTrials.gov Identifier: NCT03164902|
Recruitment Status : Unknown
Verified December 2018 by Proteus Digital Health, Inc..
Recruitment status was: Active, not recruiting
First Posted : May 24, 2017
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic Nonadherence, Patient||Device: Digital Medicine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||253 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Sponsor will be blinded from any interim analysis results (except for safety outcomes) until the final analysis. A data monitoring committee has been formed to review interim analyses for study futility and safety.|
|Official Title:||Evaluation of Wirelessly Observed Therapy to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence to Treatment|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Experimental: 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.
Device: 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).
- SVR12 Rate [ Time Frame: 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
- SVR4 Rate [ Time Frame: 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
- Ingestion Adherence [ Time Frame: 8 to 16 weeks (during therapy) ]Mean ingestion adherence to the primary hepatitis C therapy measured by the digital medicine offering
- Safety Profile:Summary details of all adverse events during the study [ Time Frame: Up to 24 weeks ]Summary details of all adverse events during the study
- Subject Satisfaction [ Time Frame: 4 weeks following completion of their hepatitis C therapy ]Feedback from subjects during the study via a survey form
- Treatment efficiency [ Time Frame: Up to 24 weeks ]Number of clinic and lab visits and other resources used during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164902
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Zuckerberg San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|United States, Colorado|
|Peak Gastroenterology Associates|
|Colorado Springs, Colorado, United States, 80907|
|Denver, Colorado, United States, 80204|
|United States, District of Columbia|
|Providence Health System|
|Washington, District of Columbia, United States, 20017|
|United States, Florida|
|Orlando Immunology Center|
|Orlando, Florida, United States, 32803|
|Apex Clinical Research|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|The Ruth M. Rothstein CORE Center|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|The Research Institute|
|Springfield, Massachusetts, United States, 01105|
|United States, Michigan|
|Harper University Hospital|
|Detroit, Michigan, United States, 48201|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, New Mexico|
|Southwest Care Center|
|Santa Fe, New Mexico, United States, 87502|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|United States, Wisconsin|
|SSM Health Dean Medical Group|
|Madison, Wisconsin, United States, 53713|
|Principal Investigator:||Mark Sulkowski, MD||Johns Hopkins University|