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OpenTrials
Completed

NCT Number: NCT05062408

Impact of the Sustained Viral Response of Chronic Hepatitis c After Treatment With Direct Action Antivirals

The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen macarena

Seville, 41009, Spain

About this study

This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with chronic liver disease caused by virus C.
  • Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
  • Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan> 10 kPa, an APRI index> 1.5 and / or a FIB-4 index> 3.25. For its part, cirrhosis was defined such as a Fibroscan> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.

Exclusion criteria

  • Coinfection by virus B or HIV.
  • Development of HCC before or during treatment.
  • Abuse of alcohol intake or addiction to parenteral drugs.
  • Liver disease of non-viral etiology (autoimmune, toxic, metabolic).

Treatment and study plan

Primary outcomes

  1. Number of patients with a progression of liver injury.

    Time frame: Up to 4 weeks

    To assess the evolution of liver injury with fibrosis data in patients who achieved SVR after treatment with direct-acting antivirals.

Secondary outcomes

  1. Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.

    Time frame: Up to 4 weeks.

    Development of hepatic decompensation, defined as a patient with ascites, spontaneous bacterial peritonitis (PBR), digestive bleeding of varicose origin, or hepatic encephalopathy at some point in the evolution from SVR until the end of study follow-up.

  2. Rate of risk factors presented by patients.

    Time frame: Up to 4 weeks.

    Identify risk factors in patients who develop liver complications after achieving sustained viral response.

  3. Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications.

    Time frame: Up to 4 weeks.

    To determine if there is a relationship between the absence of improvement in non-invasive fibrosis parameters and the development of liver complications.

  4. Clinical and fibrosis data.

    Time frame: Up to 4 weeks.

    To compare the clinical and fibrosis data between patients who develop liver complications and those who do not.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

Impact of the Sustained Viral Response on the Natural History Chronic Hepatitis c After Treatment With Direct Action Antivirals

Acronym: Hepatitis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 30, 2021
Registry last updated
Nov 17, 2021

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.

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