Epclusa for Chronic Hepatitis C

Recruiting in Palo Alto (17 mi)

Overseen by Marc G Ghany, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure.

Research Team

Marc G Ghany, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria

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.

Inclusion Criteria

I had successful hepatitis treatment with medication and a liver biopsy before treatment.

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.

Exclusion Criteria

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.

Treatment Details

Interventions

• Epclusa (Direct Acting Antiviral Agent)

Trial Overview 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.

Participant Groups

Group I: Phase I Experimental Treatment 1 Intervention

Phase I treatment

Group II: Phase II after Phase I Active Control 1 Intervention

Participants who achieved SVR12 in Phase I

Group III: Phase II without Phase I Active Control 1 Intervention

Participants who achieved SVR 24 previously

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.