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Direct Acting Antiviral Agent

Epclusa for Chronic Hepatitis C

Phase 4
Waitlist Available
Led By Marc G Ghany, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase I Treatment: Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only
Phase I Treatment: Confirmation of chronic HCV infection documented by a liver biopsy performed prior to screening visit showing evidence of chronic hepatitis
Must not have
Phase I Treatment: Prior treatment with a NS5a agent
Phase I Treatment: Various exclusions related to clinically significant illness, major medical disorders, gastrointestinal disorders, decompensated liver disease, solid organ transplantation, significant pulmonary or cardiac disease, history of malignancy, chronic liver disease of non-HCV etiology, harmful drinking, co-infection with HIV, clinically relevant drug abuse, contraindicated medications, immunosuppressive agents, hypersensitivity to specific drugs, hepatocellular carcinoma, active psychiatric problems, and conditions that may interfere with study participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 480 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study why some people still have liver complications after being cured of hepatitis C. Eligible participants will have different tests and some will take medication for 12 weeks. Then they will have follow-up visits for up to 10 years.

Who is the study for?
Adults over 18 with chronic hepatitis C, either untreated or previously treated but not cured. They must have a liver biopsy showing chronic hepatitis and meet specific health criteria like normal bilirubin levels and platelet counts. Pregnant women, those unable to use contraception, people with other significant diseases or conditions that could interfere with the study drug's absorption are excluded.
What is being tested?
The trial is testing Epclusa in individuals who've achieved sustained virological response after direct-acting antiviral agents for hepatitis C. It includes initial hospital admission for tests, daily medication for 12 weeks followed by blood tests, then biannual visits for up to 10 years including various screenings and procedures.
What are the potential side effects?
While the description doesn't list side effects specifically for Epclusa, common ones may include headache, fatigue, nausea, insomnia and sometimes more serious reactions like reactivation of Hepatitis B in those who have had it before.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have either never been treated or have not responded to previous hepatitis treatments.
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I have chronic hepatitis C confirmed by a liver biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with an NS5a agent.
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I do not have major health issues that could affect my participation in the study.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~480 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 480 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I - SVR 12
Phase II: Liver-related clinical outcome, HCC, or liver-related mortality

Side effects data

From 2019 Phase 2 & 3 trial • 10 Patients • NCT02825212
40%
Increased fatigue
30%
nausea and abdominal pain
20%
Urinary frequency and/or dysuria
10%
Herpes Zoster
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pts With Hep C Virus Infection-Related Cryoglobulinemia

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase IExperimental Treatment1 Intervention
Phase I treatment
Group II: Phase II after Phase IActive Control1 Intervention
Participants who achieved SVR12 in Phase I
Group III: Phase II without Phase IActive Control1 Intervention
Participants who achieved SVR 24 previously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epclusa
2016
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,446 Previous Clinical Trials
4,331,711 Total Patients Enrolled
Marc G Ghany, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
13 Previous Clinical Trials
1,346 Total Patients Enrolled

Media Library

Epclusa (Direct Acting Antiviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03520660 — Phase 4
Chronic Hepatitis C Research Study Groups: Phase II after Phase I, Phase I, Phase II without Phase I
Chronic Hepatitis C Clinical Trial 2023: Epclusa Highlights & Side Effects. Trial Name: NCT03520660 — Phase 4
Epclusa (Direct Acting Antiviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03520660 — Phase 4
~69 spots leftby Dec 2032
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