Long Term Follow-up of Hepatitis C Cured Patients

NCT03246048 | Completed

• 1 other identifier: PR(AG)136/2017
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Hepatitis C; Chronic Liver Disease; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Incidence of liver decompensation and/or death and hepatocellular carcinoma

  Incidence of liver related events (decompensation and hepatocellular carcinoma) during follow-up

  5 years

Secondary Outcomes (1)

• Correlate values of liver stiffness with histology changes at the end of follow up

  5 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• History of liver decompensation.
• Hepatitis B virus coinfection.
• HIV infection.
• Prior liver transplantation.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Genescà

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09