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

NCT02439567 | Completed

• 1 other identifier: SPLEEN-C (JOA-SOF-2015-01)
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis C; Cirrhosis; Portal Hypertension

Keywords

Cirrhosis; Chronic hepatitis C; Clinically significant portal hypertension; Portal hypertension; Elastography; Antiviral therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

Patients

EXPERIMENTAL

Treatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography

Device: Fibroscan: Liver and Spleen elastography

Interventions

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.

Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Chronic liver disease due to other etiology than HCV.
• Terminal illness.
• Treatment with interferon.
• Liver stiffness measurement \< 10 kPa at baseline.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

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

Study Officials

• Joan Genescà Ferrer, PhD MD

  Hospital Universitari Vall d'hebron Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 8, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

ES (1)