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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

DASH 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. 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

DASH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SVR12 Rate
Secondary outcome measures
Ingestion Adherence
SVR4 Rate
Safety Profile:Summary details of all adverse events during the study
+1 more
Other outcome measures
Treatment efficiency

DASH 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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Who is running the clinical trial?

Proteus Digital Health, Inc.Lead Sponsor
10 Previous Clinical Trials
1,121 Total Patients Enrolled
Mark Sulkowski, MDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
1,080 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence
2017. "Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03164902.
All > Autoimmune Hepatitis > Hepatitis C
~33 spots leftby Apr 2025
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