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Direct-Acting Antiviral

Harvoni x 8 or 12 weeks for Hepatitis C

Phase 4
Waitlist Available
Led By Mark Mailliard, MD
Research Sponsored by University of Nebraska
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 12 weeks after the end of harvoni therapy
Awards & highlights

Study Summary

To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection

Eligible Conditions
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after the end of harvoni therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after the end of harvoni 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
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Secondary outcome measures
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR

Side effects data

From 2020 Phase 4 trial • 16 Patients • NCT02759861
47%
Fatigue
20%
Headache
7%
Agitation
7%
Nausea
7%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Harvoni x 8 or 12 Weeks

Trial Design

1Treatment groups
Experimental Treatment
Group I: Harvoni x 8 or 12 weeksExperimental Treatment1 Intervention
patient will receive 8 or 12 weeks depending on clinical data
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ledipasvir
FDA approved

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
536 Previous Clinical Trials
1,143,906 Total Patients Enrolled
4 Trials studying Hepatitis C
11 Patients Enrolled for Hepatitis C
Mark Mailliard, MDPrincipal InvestigatorUNMC

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
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
Mark Mailliard, MD 2016. "Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02759861.
~2 spots leftby Apr 2025
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