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

NCT05062408 | Completed

• 1 other identifier: FIS-ANT- 2021-01
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of patients with a progression of liver injury.

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

  Up to 4 weeks

Secondary Outcomes (4)

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

  Up to 4 weeks.

• Rate of risk factors presented by patients.

  Up to 4 weeks.

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

  Up to 4 weeks.

• Clinical and fibrosis data.

  Up to 4 weeks.

Study Arms (1)

cases

Patients treated with direct-acting antivirals.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population are patients with chronic hepatitis C who have been treated with direct-acting antivirals between 2014 and 2017. Also patients with fibrosis and liver cirrhosis.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

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

• Paula Fernández Álvarez

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 30, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-01

Locations

ES (1)