Long Term Follow-up of Hepatitis C Cured Patients (NCT03246048) | Clinical Trial Compass
CompletedNot Applicable
Long Term Follow-up of Hepatitis C Cured Patients
300 participantsStarted 2016-01
Plain-language summary
Objectives:
The general objective of the present project is to gain a better understanding of disease outcome in cACLD patients treated with the new oral DAA. In particular, the project will focus on:
\- To evaluate the long term prognosis of patients with compensated advanced chronic liver disease (cACLD) who achieve sustained virological response (SVR) after the new oral direct-acting antiviral agents (DAA), and determine clinical and elastographic basal and follow-up parameters to identify low and high risk groups of developing liver-related decompensation.
Methods:
Prospective cohort study in patients with cACLD in whom basal and annual clinical features and liver stiffness measurements (LSM) will be performed, and survival free of liver-related events will be analyzed.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients having suggestive or highly suggestive cACLD defined as LSM 10-15 kPa or LSM ≥15 kPa, respectively. Patients with suggestive cACLD (LSM 10-15 kPa) will be divided in two subgroups depending on the presence of at least one of the following: gastroesophageal varices, hepatic venous pressure gradient (HVPG) \>5 mmHg, nodular liver or collateral circulation in US, splenomegaly (\>=13 cm) or platelet count \<150,000. Patients with suggestive cACLD (LSM 10-15 kPa) and none of the prior characteristics will form the subgroup of occult cACLD.
. Age between 18-85 years old.
. SVR after antiviral therapy.
. Signed informed consent.
Exclusion criteria
. History of liver decompensation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of liver decompensation and/or death and hepatocellular carcinoma
Timeframe: 5 years
Trial details
NCT IDNCT03246048
SponsorHospital Universitari Vall d'Hebron Research Institute