Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

12. prosince 2018 aktualizováno: 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.

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

253

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
SVR12 Rate
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
SVR4 Rate
Časové okno: 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
Časové okno: 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
Časové okno: Up to 24 weeks
Summary details of all adverse events during the study
Up to 24 weeks
Subject Satisfaction
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Treatment efficiency
Časové okno: Up to 24 weeks
Number of clinic and lab visits and other resources used during the study
Up to 24 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Proteus Digital Health, Inc.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. července 2017

Primární dokončení (Očekávaný)

30. dubna 2019

Dokončení studie (Očekávaný)

30. dubna 2019

Termíny zápisu do studia

První předloženo

22. května 2017

První předloženo, které splnilo kritéria kontroly kvality

23. května 2017

První zveřejněno (Aktuální)

24. května 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. prosince 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. prosince 2018

Naposledy ověřeno

1. prosince 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PB-WOTFORHEPC

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Hepatitida C, chronická

Klinické studie na Digital Medicine

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Portugal

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit