Hepatitis C, ChronicDASHNCT03164902
Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence
A study testing Digital Medicine in people with Hepatitis C, Chronic and Nonadherence, Patient, run by Proteus Digital Health, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Nonadherence, Patient
- What is being tested?
- Digital Medicine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 16 sitesUnited States
- Study dates
- 21 Jul 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must meet ALL of the following criteria to be considered for enrollment into this study:
- Adults (≥18 years old) who are diagnosed with hepatitis C deemed chronic by the investigator
- 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)
- One of more of the following risk factors for nonadherence:
- Active alcohol or substance abuse (positive urine drug screen, illicit use in past 3 months, and/or in opioid substitution program), OR
- Patient reported history of hospitalization within past 2 years for a psychiatric comorbidity, OR
Show all 16Show fewer
- Evidence of nonadherence to medications (e.g. self-report or refill history indicative of nonadherence), OR
- History of at least one missed clinic visit for hepatitis management, OR
- 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
- Study subject has daily access to a telephone for communicating with the study personnel and study personnel contacting the study subject
- Ability to read and understand the instructions for the study.
- Willingness to adhere to all study procedures (both onsite and offsite), including troubleshooting of the product by a third-party, if needed.
- Capacity to and willing to provide informed consent. All subjects must have a signed informed consent document prior to participating in this study
- Currently owns and uses a smart phone or tablet, or has capacity to learn use of study mobile device as determined by investigator.
- 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).
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama
Birmingham, Alabama, 35294
The Ruth M. Rothstein CORE Center
Chicago, Illinois, 60637
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Denver Health
Denver, Colorado, 80204
Harper University Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
SSM Health Dean Medical Group
Madison, Wisconsin, 53713
Orlando Immunology Center
Orlando, Florida, 32803
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Southwest Care Center
Santa Fe, New Mexico, 87502
Harborview Medical Center
Seattle, Washington, 98104
The Research Institute
Springfield, Massachusetts, 01105
Apex Clinical Research
Tampa, Florida, 33612
Providence Health System
Washington D.C., District of Columbia, 20017
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C, Chronic, Nonadherence, Patient
- Being tested
- Digital Medicine
- Medical subject headings
- Hepatitis C, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital MedicineDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Digital Medicine Arm | Experimental | 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. Receives: Device: Digital Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12 Rate
Proportion of subjects achieving sustained viral response, 12 weeks following completion of their hepatitis C therapy
Measured: 12 weeks following completion of their hepatitis C therapy
Secondary outcomes (4)
SVR4 Rate
Proportion of subjects achieving sustained viral response, 4 weeks following completion of their hepatitis C therapy
Measured: 4 weeks following completion of their hepatitis C therapy
Ingestion Adherence
Mean ingestion adherence to the primary hepatitis C therapy measured by the digital medicine offering
Measured: 8 to 16 weeks (during therapy)
Safety Profile:Summary details of all adverse events during the study
Summary details of all adverse events during the study
Measured: Up to 24 weeks
Subject Satisfaction
Feedback from subjects during the study via a survey form
Measured: 4 weeks following completion of their hepatitis C therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start21 Jul 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proteus Digital Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sulkowski, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164902
- Sponsor's protocol ID
- PB-WOTFORHEPC
- Acronym
- DASH
- Status last verified
- Dec 2018
- First submitted
- 22 May 2017
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.
PubMed 16702586Younossi ZM, Park H, Gordon SC, Ferguson JR, Ahmed A, Dieterich D, Saab S. Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C. Am J Manag Care. 2016 May;22(6 Spec No.):SP205-11.
PubMed 27266950Sulkowski M, Luetkemeyer AF, Wyles DL, Martorell C, Muir A, Weisberg I, Gordon SC, McLain R, Huhn G. Impact of a digital medicine programme on hepatitis C treatment adherence and efficacy in adults at high risk for non-adherence. Aliment Pharmacol Ther. 2020 Jun;51(12):1384-1396. doi: 10.1111/apt.15707. Epub 2020 Apr 30.
PubMed 32352586
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wirelessly Observed Therapy to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence to Treatment
- ClinicalTrials.gov ID
- NCT03164902
- Acronym / sponsor ID
- DASH / PB-WOTFORHEPC
- Conditions
- Hepatitis C, Chronic, Nonadherence, Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Proteus Digital Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Medicine Arm | Experimental | Device: Digital MedicineSubjects enrolled in this single arm study will be directed to use digital medicine versions of their hepatitis C therapy for the duration of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- A subject must meet ALL of the following criteria to be considered for enrollment into this study:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital MedicineThe 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). | Device | Digital Medicine Arm |
Primary outcome
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
4 secondary outcomes
SVR4 Rate
Time frame: 4 weeks following completion of their hepatitis C therapy
Ingestion Adherence
Time frame: 8 to 16 weeks (during therapy)
Safety Profile:Summary details of all adverse events during the study
Time frame: Up to 24 weeks
Subject Satisfaction
Time frame: 4 weeks following completion of their hepatitis C therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Background: PubMed 16702586Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.
- Background: PubMed 27266950Younossi ZM, Park H, Gordon SC, Ferguson JR, Ahmed A, Dieterich D, Saab S. Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C. Am J Manag Care. 2016 May;22(6 Spec No.):SP205-11.
- Derived from this study: PubMed 32352586Sulkowski M, Luetkemeyer AF, Wyles DL, Martorell C, Muir A, Weisberg I, Gordon SC, McLain R, Huhn G. Impact of a digital medicine programme on hepatitis C treatment adherence and efficacy in adults at high risk for non-adherence. Aliment Pharmacol Ther. 2020 Jun;51(12):1384-1396. doi: 10.1111/apt.15707. Epub 2020 Apr 30.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Sulkowski, MD principal investigator
Johns Hopkins University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Medicine in people with Hepatitis C, Chronic and Nonadherence, Patient, run by Proteus Digital Health, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 Rate (time frame: 12 weeks following completion of their hepatitis C therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164902, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.