Long Term Follow-up of Hepatitis C Cured Patients

September 19, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

Predicting Outcomes in Hepatitis C Patients With Compensated Advanced Chronic Liver Disease Cured With New Antivirals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

HYPOTHESIS:

- The prognosis of cACLD patients who achieve SVR will improve during follow-up and this will be reflected in an improvement in liver and spleen stiffness and reduction of liver-related events. However, on an individual basis, because of many confounding factors, predictability is unknown.

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 determine simple clinical and elastographic basal and follow-up parameters to identify low and high risk groups for developing liver-related decompensation in cACLD patients who achieve SVR after DAA therapy. As a consequence of this, to provide guidance to clinicians to decide which cACLD patients should be indefinitely followed and which ones can be discharged from follow up, and also provide solid information to patients regarding the possible outcome of their cACLD after SVR.

  • Study design: Prospective cohort study in an academic center to evaluate long term prognosis of patients with cACLD who achieve SVR after DAA therapy.
  • Research subjects: All consecutive patients meeting inclusion criteria who have received DAA therapy from 1st January 2015 to 31st March 2016.
  • Variables: Variables will be collected at baseline and annually for a period of 5 years. Basal data on genotype/subtype, interleukin 28B, viremia, type and duration of therapy. Data of liver function (INR, albumin, bilirubin), platelet count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), gamma-glutamyltransferase (GGT), US findings (spleen size, collaterals), liver and spleen stiffness, body mass index (BMI), presence of metabolic syndrome factors (diabetes, dyslipemia, hypertension), alcohol and tabacco use, treatment with statins and development of liver-related events. The subgroup of patients with known esophageal varices prior to therapy will receive a second endoscopy 12-18 months after finishing therapy. Liver biopsies will be performed (after consent) at the end of follow-up (5 years) in the group of patients who will be candidates for being discharged (LSM<10 kPa) to ensure cirrhosis regression and learn about the correlation between LSM and histology after SVR.
  • Data collection methods and analysis: Patients will be monitored at the outpatient clinics every 6 months as per usual clinical practice. Every 6 months, clinical data, laboratory tests and abdominal US will be obtained. Liver and spleen stiffness (Fibroscan, Echosens) will be performed annually after finishing treatment by an experienced member (MP), using usual quality criteria. Spleen stiffness measurements will be performed under US spleen localization and with the same device and conditions than liver stiffness. All data will be registered in a database.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients meeting inclusion criteria who have received DAA therapy from 1st January 2015 to 31st March 2016.

Description

Inclusion Criteria:

  1. 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.
  2. Age between 18-85 years old.
  3. SVR after antiviral therapy.
  4. Signed informed consent.

Exclusion Criteria:

  1. History of liver decompensation.
  2. Hepatitis B virus coinfection.
  3. HIV infection.
  4. Prior liver transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of liver decompensation and/or death and hepatocellular carcinoma
Time Frame: 5 years
Incidence of liver related events (decompensation and hepatocellular carcinoma) during follow-up
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlate values of liver stiffness with histology changes at the end of follow up
Time Frame: 5 years
Correlate liver fibrosis in liver biopsy with liver stiffness cut-offs.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitari Vall d'Hebron Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joan Genescà, Hospital Vall d'Hebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR(AG)136/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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