Digital Medicine Arm for Chronic Hepatitis C (DASH Trial)

N/A

Waitlist Available

Led By Mark Sulkowski, MD

Research Sponsored by Proteus Digital Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 to 16 weeks (during therapy)

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Chronic Hepatitis C
Noncompliance

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 to 16 weeks (during therapy)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 to 16 weeks (during therapy)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 to 16 weeks (during therapy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SVR12 Rate

Secondary study objectives

Ingestion Adherence

SVR4 Rate

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

+1 more

Other study objectives

Treatment efficiency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Digital Medicine ArmExperimental Treatment1 Intervention

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.

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