NCT02439567

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Hepatitis C
• Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DEVICE	Fibroscan: Liver and Spleen elastography	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2015-05-08
• Last updated: 2017-05-11

Locations

1 site across 1 country: Spain