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

NCT03164902 | Unknown DMC FDA Device

• 1 other identifier: PB-WOTFORHEPC
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 16

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.

Conditions

Hepatitis C, Chronic; Nonadherence, Patient

Outcome Measures

Primary Outcomes (1)

• SVR12 Rate

  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

Secondary Outcomes (4)

• SVR4 Rate

  4 weeks following completion of their hepatitis C therapy

• Ingestion Adherence

  8 to 16 weeks (during therapy)

• Safety Profile:Summary details of all adverse events during the study

  Up to 24 weeks

• Subject Satisfaction

  4 weeks following completion of their hepatitis C therapy

Other Outcomes (1)

• Treatment efficiency

  Up to 24 weeks

Study Arms (1)

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.

Device: Digital Medicine

Interventions

Digital Medicine DEVICE

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).

Digital Medicine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• ANY 1 of the following will exclude a subject from being enrolled into the study:
• \. 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.
• \. Positive pregnancy test during screening 13. Inability to swallow the test capsule

Sponsors & Collaborators

• Proteus Digital Health, Inc.: lead

Study Sites (16)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Providence Health System

Washington D.C., District of Columbia, 20017, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Apex Clinical Research

Tampa, Florida, 33612, United States

Location

The Ruth M. Rothstein CORE Center

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Harper University Hospital

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Southwest Care Center

Santa Fe, New Mexico, 87502, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

SSM Health Dean Medical Group

Madison, Wisconsin, 53713, United States

Location

Related Publications (3)

• 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.

  PMID: 16702586 BACKGROUND

• Younossi 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.

  PMID: 27266950 BACKGROUND

• Sulkowski 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.

  PMID: 32352586 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Patient Compliance

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mark Sulkowski, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: July 21, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (16)