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

NCT ID: NCT02439567

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients

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

Group Type: EXPERIMENTAL

Fibroscan: Liver and Spleen elastography

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Genescà Ferrer, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'hebron Barcelona, Spain

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Countries

Spain

Other Identifiers

SPLEEN-C (JOA-SOF-2015-01)

Identifier Type: -

Identifier Source: org_study_id