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

12 de dezembro de 2018 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

253

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Dispositivo: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
SVR12 Rate
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
SVR4 Rate
Prazo: 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
Prazo: 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
Prazo: Up to 24 weeks
Summary details of all adverse events during the study
Up to 24 weeks
Subject Satisfaction
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Treatment efficiency
Prazo: Up to 24 weeks
Number of clinic and lab visits and other resources used during the study
Up to 24 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Proteus Digital Health, Inc.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de julho de 2017

Conclusão Primária (Antecipado)

30 de abril de 2019

Conclusão do estudo (Antecipado)

30 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

22 de maio de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de maio de 2017

Primeira postagem (Real)

24 de maio de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de dezembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de dezembro de 2018

Última verificação

1 de dezembro de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PB-WOTFORHEPC

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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