Skip to main content
OpenTrials
Completed

NCT Number: NCT02758509

Impact of Antiviral Therapy on Gastroesophageal Varices.

Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Signed informed consent.
  • Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
  • Liver cirrhosis (transient elastography ≥ 14 kPa).
  • Baseline upper gastrointestinal endoscopy to assess gastroesophageal varices

Exclusion criteria

  • Negative to provide signed informed consent.
  • Negative to perform gastrointestinal endoscopy

Treatment and study plan

Pegylated interferon alfa-2a + Ribavirin

Drug

Pegylated interferon alfa-2a + Ribavirin + Boceprevir

Drug

Pegylated interferon alfa-2a + Ribavirin +Telaprevir

Drug

Ledipasvir/Sofosbuvir

Drug

Ombitasvir/paritaprevir/ritonavir+Dasabuvir

Drug

Daclatasvir+Sofosbuvir

Drug

Simeprevir+Sofosbuvir

Drug

Primary outcomes

  1. sustained virological response (SVR)

    Time frame: 12 weeks after treatment completion

    undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment

Secondary outcomes

  1. Number of patients with gastroesophageal varices

    Time frame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion

    Number of patients with GOV before and 12-24 weeks after treatment completion in patients with or without SVR

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices.

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
May 2, 2016
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.