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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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cases

Patients treated with direct-acting antivirals.

No interventions assigned to this group

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Fernández Álvarez

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

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Hospital Universitario Virgen macarena

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIS-ANT- 2021-01

Identifier Type: -

Identifier Source: org_study_id