NCT04191018: GOVaSViR

GastrOesophageal Varices After Sustained Virological Response

Status unknown Last updated 9 December 2019

What this trial tests

trial testing Liver elastography in Liver Diseases in 322 participants. Status unknown.

Timeline

26 November 2019

Primary endpoint
14 August 2022

28 February 2024

Quick facts

Lead sponsor	Oswaldo Cruz Foundation
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	322
Start date	26 November 2019
Primary completion	14 August 2022
Estimated completion	28 February 2024
Sites	2 locations across Brazil

Drugs / interventions tested

• Liver elastography
• Splenic elastography
• Gastrointestinal endoscopy

Conditions studied

• Liver Diseases — all drugs for Liver Diseases →
• Hepatitis C — all drugs for Hepatitis C →

Sponsor

Oswaldo Cruz Foundation

Who can join

Adults 18 to 99, any sex, with Liver Diseases or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.