Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cured of hepatitis c? this study follows patients for 10 years to see what happens next

NCT ID NCT03520660

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 9 times

Summary

This study follows 121 adults who have been cured of chronic hepatitis C to understand why some still develop liver complications like scarring or cancer. Participants are monitored for up to 10 years with regular tests, scans, and occasional liver biopsies. The goal is to learn more about long-term health after a hepatitis C cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sofosbuvir/velpatasvir (Epclusa)
What this could lead to
If successful, this study could reveal why some people develop liver problems even after being cured of hepatitis C, potentially guiding better long-term care.
What could go wrong
This is an observational follow-up study, not a test of a new treatment. It may not find clear reasons for complications, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

121 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Phase I Treatment * Male or female \>= 18 years of age * Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only * Confirmation of chronic HCV infection documented by: * A positive HCV RNA or positive HCV genotyping test at least 6-months prior to the Baseline/Day 1 visit * A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis. * Subjects must have the following laboratory parameters at screening: * ALT \<= 10 x the upper limit of normal (ULN) * AST \<= 10 x ULN * Total bilirubin \<2.5 mg/dL, Direct bilirubin \<= 1.5 ULN * Platelets \>= 50,000 K/mm\^3 * HbA1c \<= 8.5% * Hemoglobin \>= 10g/dL * Albumin \>= 3g/dL * INR \<= 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR. * HCV RNA positive at screening. * Subjects must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator. Phase II Follow-up * Male or female \>= 18 years of age. * SVR24 following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment. * Subject must be of generally good health as determined by the Investigator. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Phase I Treatment * Pregnancy or lactation * Inability to practice one form of adequate contraction for females of childbearing potential * Prior treatment with a NS5a agent * Current or prior history of any of the following: * Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded * Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug * Decompensated liver disease as defined by serum bilirubin \>= 2.5 mg/dL (with direct bilirubin \>= 1.5 mg/dL), INR \>1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy * Solid organ transplantation * Significant pulmonary disease, significant cardiac disease * History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy \<5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin). * Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis). * Evidence of harmful or hazardous drinking as defined as a score \>= 8 on the AUDIT questionnaire. * Co-infection with HIV defined as the presence of anti-HIV in serum. * Clinically relevant drug abuse based on patient history within 12 months of screening. * Use of medications contraindicated with use of sofosbuvir/velpatasvir within 21 days of the Baseline/Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before baseline Day 1 for the following: * Acid reducing Agents * Antiarrhythmics * Anticancer * Antimycobacterial * HIV antivirals * Herbal supplements * HMG-CoA Reductase Inhibitors * Use of antiviral medications within the last 30 days. * Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent \>= 10 mg/day). * Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients. * Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL * Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study. * Presence of conditions that, in the opinion of the investigators, would not allow the subject to n the current study for at least 1 year. Phase II Follow-up * Pregnancy * Current or prior history of any of the following: * Clinically significant illness (other than resolved HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded --Decompensated liver disease as defined by serum bilirubin \>= 2.5 mg/dL (with direct bilirubin \>= 1.5 mg/dL), INR \>1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy. * Solid organ transplantation * Significant pulmonary disease, significant cardiac disease * History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy \<5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin) * Chronic liver disease with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis) * Evidence of harmful or hazardous drinking as defined as a score \>= 8 on the AUDIT questionnaire * Co-infection with HIV defined as the presence of anti-HIV in serum * Clinically relevant drug abuse based on patient history within 12 months of screening * Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent \>= 10 mg/day) * Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL * Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study * Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiovascular diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.