GastrOesophageal Varices After Sustained Virological Response (GOVaSViR)

December 5, 2019 updated by: Oswaldo Cruz Foundation

Progression of Gastroesophageal Varices After Sustained Virological Response by Interferon-free Regimens in Patients With Advanced Fibrosis / Cirrhosis Due to Chronic Hepatitis C

Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients.

Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography <20kPa and a platelet count >150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro/RJ
      • Rio de Janeiro, Rio De Janeiro/RJ, Brazil, 21040-360
        • Recruiting
        • Evandro Chagas National Institute of Infectious Diseases

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

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced fibrosis or cirrhosis with sustained virologic response by direct-acting agents for HCV treatment

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Presence of advanced fibrosis or cirrhosis (stage F≥3 METAVIR) based on liver stiffness by transient elastography (≥ 9,5 kPa) or liver biopsy
  • Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment
  • Liver stiffness measurement at least 18 months after SVR

Exclusion Criteria:

  • Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases
  • Liver transplantation
  • Presence of high volume ascites or hepatocellular carcinoma
  • Participation in programs of esophageal band ligation for eradication of esophageal varices
  • Presence of signs of acute decompensated liver disease

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

Outcome Measure
Measure Description
Time Frame
Incidence of esophageal varices (portal hypertension) after SVR
Time Frame: up to 48 months after SVR
Evaluation of presence/absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis compared to before treatment
up to 48 months after SVR
Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR
Time Frame: up to 48 months after SVR
Validation of the diagnostic performance of non-invasive tests (liver and splenic stiffness or biological markers) to screen esophageal varices in patients with advanced fibrosis/cirrhosis after SVR by DAA treatment for HCV
up to 48 months after SVR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of regression of esophageal varices after SVR
Time Frame: up to 48 months after SVR
Evaluation of absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis and esophageal varices before treatment
up to 48 months after SVR

Collaborators and Investigators

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

Sponsor

Oswaldo Cruz Foundation

Investigators

  • Principal Investigator: Hugo Perazzo, PhD, Oswaldo Cruz Foundation

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 (ANTICIPATED)

November 26, 2019

Primary Completion (ANTICIPATED)

August 14, 2022

Study Completion (ANTICIPATED)

February 28, 2024

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (ACTUAL)

December 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10320319.6.0000.5262

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.

Clinical Trials on Liver Diseases

Clinical Trials on Liver elastography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe