This trial is active, not recruiting.

Conditions chronic hepatitis c, cirrhosis, portal hypertension
Treatment fibroscan: liver and spleen elastography
Phase phase 4
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Start date January 2015
End date July 2016
Trial size 41 participants
Trial identifier NCT02439567, SPLEEN-C (JOA-SOF-2015-01)


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Treatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography
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.

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

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Usefulness of Transient Elastography Assessing Liver Fibrosis and Portal Hypertension in Patients With HCV Cirrhosis Treated With New All Oral Antiviral Drugs
Principal investigator Joan Genescà Ferrer, PhD MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.