Epclusa for Chronic Hepatitis C

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Chronic Hepatitis C+2 MoreEpclusa - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Chronic Hepatitis C
  • Cardiovascular Disease
  • Diabetes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 480 Weeks

24 weeks
Phase I - SVR 12
480 Weeks
Phase II: Liver-related clinical outcome, HCC, or liver-related mortality
480 weeks
Phase II: All-cause mortality
Phase II: Assess Regression in Portal Hypertension
Phase II: Change in Fibroscan
Phase II: Change in Ishak fibrosis score
Phase II: HCC
Phase II: all-cause mortality

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Side Effects for

Pts With Hep C Virus Infection-Related Cryoglobulinemia
40%Increased fatigue
30%nausea and abdominal pain
20%Urinary frequency and/or dysuria
10%Herpes Zoster
This histogram enumerates side effects from a completed 2019 Phase 2 & 3 trial (NCT02825212) in the Pts With Hep C Virus Infection-Related Cryoglobulinemia ARM group. Side effects include: Increased fatigue with 40%, nausea and abdominal pain with 30%, Urinary frequency and/or dysuria with 20%, Herpes Zoster with 10%.

Trial Design

3 Treatment Groups

Phase II after Phase I
1 of 3
Phase II without Phase I
1 of 3
Phase I
1 of 3

Active Control

Experimental Treatment

350 Total Participants · 3 Treatment Groups

Primary Treatment: Epclusa · No Placebo Group · Phase 4

Phase I
Drug
Experimental Group · 1 Intervention: Epclusa · Intervention Types: Drug
Phase II after Phase INoIntervention Group · 1 Intervention: Phase II after Phase I · Intervention Types:
Phase II without Phase INoIntervention Group · 1 Intervention: Phase II without Phase I · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofosbuvir
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 480 weeks

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,141 Previous Clinical Trials
4,064,125 Total Patients Enrolled
Marc G Ghany, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
12 Previous Clinical Trials
1,663 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Liver biopsy performed prior to screening visit showing evidence of chronic hepatitis.
You have received phase I treatment.\n
You are female or male and are at least 18 years of age.
Platelets > 50,000 K/mm3.
HbA1c < 8.