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

May 10, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Treatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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).
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Joan Genescà Ferrer, PhD MD, Hospital Universitari Vall d'hebron Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLEEN-C (JOA-SOF-2015-01)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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