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Direct Acting Antiviral Agent
Epclusa for Chronic Hepatitis C
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 480 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have either never been treated or have not responded to previous hepatitis treatments.
Select...
I have chronic hepatitis C confirmed by a liver biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 480 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~480 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I - SVR 12
Phase II: Liver-related clinical outcome, HCC, or liver-related mortality
Secondary outcome measures
Phase II: All-cause mortality
Phase II: Assess Regression in Portal Hypertension
Phase II: Change in Fibroscan
+2 moreSide effects data
From 2019 Phase 2 & 3 trial • 10 Patients • NCT0282521240%
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
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
2,358 Previous Clinical Trials
4,314,891 Total Patients Enrolled
Marc G Ghany, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
13 Previous Clinical Trials
1,329 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had successful hepatitis treatment with medication and a liver biopsy before treatment.I have previously been treated with an NS5a agent.I do not have major health issues that could affect my participation in the study.I am not pregnant or breastfeeding.I do not have major health issues that could affect my participation in the study.I have either never been treated or have not responded to previous hepatitis treatments.I have had chronic hepatitis C confirmed by a test more than 6 months ago.I am 18 years old or older.I have chronic hepatitis C confirmed by a liver biopsy.I am 18 years old or older.My overall health is good, as confirmed by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II after Phase I
- Group 2: Phase I
- Group 3: Phase II without Phase I
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted approval of Epclusa?
"The safety of Epclusa has been confirmed by multiple clinical trials, earning it a score of 3. This is noteworthy as this drug is already approved and currently available to patients."
Answered by AI
Are there any available slots in this clinical trial for prospective participants?
"Clinicaltrials.gov currently lists this trial as actively recruiting participants, with the initial posting occurring on October 19th 2018 and a recent update on October 22nd 2022."
Answered by AI
Could you provide an estimate of the number of individuals currently enrolled in this clinical exploration?
"Affirmative. Per the data hosted on clinicaltrials.gov, this research is still accepting patients as of October 22nd 2022, having originally been posted four years earlier on October 19th 2018. 450 participants are being sought out from a single medical centre."
Answered by AI
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