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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Cirrhosis Communicable Diseases Digestive System Diseases Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Hypertension, Portal Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension RNA Virus Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibroscan: Liver and Spleen elastography

Device

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.

Primary outcomes

Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR).

Time frame: 6 months
Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR.

Time frame: 6 months

Secondary outcomes

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).

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: SPLEEN-C

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 8, 2015
Registry last updated: May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed