CompletedPhase 4

deLIVER: Direct Acting Antiviral Effects on the Liver

United States15 participantsStarted 2017-01

Plain-language summary

Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability and willingness of participant to provide written informed consent.
. Men and women age ≥18 to ≤70 years at study entry
. Body mass index (BMI) ≥ 18 kg/m2
. HCV RNA ≥ 10,000 IU/mL at Screening
. HCV genotype 1a at Screening or within 6 months of screening
. Chronic HCV infection (≥ 6 months) documented by prior medical history
. HCV treatment-naïve with no prior treatment with any IFN, RBV, or approved or experimental HCV-specific DAA
. Absence of cirrhosis as defined as transient elastography (FibroScan®) liver stiffness measurement \< 12.5 kPa within 6 months of screening

Exclusion criteria

. Breastfeeding.
. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
. Acute or serious illness requiring systemic treatment and/or hospitalization within 42 days prior to study entry.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy

Timeframe: Pre-treatment, Day 7

Trial details

NCT IDNCT02938013

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-30

Results submitted2020-09-08

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