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

Cirrhosis Clinical Trial

— SPLEEN-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439567
• Other study ID #: SPLEEN-C (JOA-SOF-2015-01)
• Status: Completed
• Phase: N/A
• First received: April 27, 2015
• Last updated: May 10, 2017
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR).		6 months
Primary	Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR.		6 months
Secondary	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