Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.

Detailed Description
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Prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in Spain. In all these patients the following parameters will be assessed: Baseline liver and spleen stiffness and CAP measurements at the time of starting therapy and then, during treatment in week 4 and week 12 (end of treatment). After finishing therapy, these measurements will be repeated at 6 and 12 months of follow-up. Routine lab tests, including liver enzymes and viral load, will be performed at baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy according to standard clinical practice. Liver ultrasound will be performed every 6 months as a routine procedure in patients wiht liver cirrhosis. Patients who were known to have esophageal varices prior to therapy will be assessed with an upper endoscopy 12 months after finishing therapy if they achieve SVR.

Official Title
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Usefulness of Transient Elastography Assessing Liver Fibrosis and Portal Hypertension in Patients With HCV Cirrhosis Treated With New All Oral Antiviral Drugs

Conditions
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Portal Hypertension, Chronic Hepatitis C, Cirrhosis

Intervention / Treatment
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* Device: Fibroscan: Liver and Spleen elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 90 years. History of chronic hepatitis C infection. Compensated advanced chronic liver disease (Baveno VI definition): Baseline liver stiffness ≥15 kPa or, Baseline liver stiffness 10-15 kPa and one of the following: platelet count <150x10e9/L, spleen size ≥13 cm, nodular liver or collateral circulation in abdominal ultrasound, HVPG >5 mmHg, upper gastrointestinal endoscopy showing gastroesophageal varices or previous liver biopsy showing bridging fibrosis or cirrhosis. Indication to start antiviral treatment with new oral drugs. Willingness to enter the study. Sign the informed consent. Exclusion Criteria: Chronic liver disease due to other etiology than HCV. Terminal illness. Treatment with interferon. Liver stiffness measurement < 10 kPa at baseline.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Treatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography | Device: Fibroscan: Liver and Spleen elastography<br>* In cirrhotic patients treated with antivirals for HCV infection, repeated liver and spleen stiffness measures with Fibroscan will be performed to predict the presence of clinically significant and severe portal hypertension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR). |  | 6 months | 
| Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (Composite outcome including survival free of all cause of death, liver transplantation, decompensation and/or increase in >1 point in Child Pugh score). |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Chronic hepatitis C, Clinically significant portal hypertension, Portal hypertension, Elastography, Antiviral therapy