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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 : Recruiting
First Posted : May 24, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Proteus Digital Health, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Nonadherence, Patient Device: Digital Medicine Not Applicable

Detailed Description:

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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Subject Satisfaction [ Time Frame: 4 weeks following completion of their hepatitis C therapy ]
    Feedback from subjects during the study via a survey form


Other Outcome Measures:
  1. Treatment efficiency [ Time Frame: Up to 24 weeks ]
    Number of clinic and lab visits and other resources used during the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Contacts
Contact: George M Savage, MD 6506376103 GSavage@proteus.com
Contact: Josefina Santos 6506376173 JSantos@proteus.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Olivia Hogue         
Contact    205-975-4285      
Principal Investigator: Michael Saag, MD         
United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Annie Luetkemeyer, MD         
United States, Colorado
Peak Gastroenterology Associates Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keyur Patel         
Contact    719-362-2270      
Principal Investigator: Bhaktasharan Patel, MD         
Denver Health Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: David Wyles, MD         
United States, District of Columbia
Providence Health System Recruiting
Washington, District of Columbia, United States, 20017
Principal Investigator: Jose Bordon, MD         
Principal Investigator: Richard Elion, MD         
United States, Florida
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: Federico Hinestrosa, MD         
Apex Clinical Research Recruiting
Tampa, Florida, United States, 33612
Contact: Naresh Nakarani         
Contact    813-605-0031      
Principal Investigator: Chandravadhan Patel, MD         
United States, Illinois
The Ruth M. Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Gregory Huhn, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Lilian Arteaga         
Principal Investigator: Mark Sulkowski, MD         
United States, Massachusetts
The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
Principal Investigator: Claudia Martorell, MD         
United States, Michigan
Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Paul Naylor, PhD         
Principal Investigator: Milton Mutchnick, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Stuart Gordon, MD         
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States, 87502
Contact: Andrea Rodriguez         
Principal Investigator: James Adams, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Stacy Smith         
Principal Investigator: Andrew Muir, MD         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Lee McKoin         
Contact    206-744-2341      
Principal Investigator: Charles Landis, MD         
United States, Wisconsin
SSM Health Dean Medical Group Recruiting
Madison, Wisconsin, United States, 53713
Contact: Brenda Grehin         
Contact    608-835-1014      
Principal Investigator: James Levin, MD         
Sponsors and Collaborators
Proteus Digital Health, Inc.
Investigators
Principal Investigator: Mark Sulkowski, MD Johns Hopkins University

Publications:
Responsible Party: Proteus Digital Health, Inc.
ClinicalTrials.gov Identifier: NCT03164902     History of Changes
Other Study ID Numbers: PB-WOTFORHEPC
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic