NCT05062408CompletedNot Applicable
Impact of the Sustained Viral Response on the Natural History Chronic Hepatitis c After Treatment With Direct Action Antivirals
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 site in 1 country321 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Number of patients with a progression of liver injury.
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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.
- •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).
Outcomes
Primary Outcomes
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
- 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.)
- Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.(Up to 4 weeks.)
Investigators
Study Sites (1)
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