Prediction of Liver-related Outcomes After HCV Cure

Hepatocellular Carcinoma Clinical Trial

Official title:

Development of a Predictive Model of Liver Complications Emergence in Patients With Advanced Fibrosis Who Achieve Sustained Virological Response With Direct-acting Antivirals-based Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460157
• Other study ID #: GEHEP-011
• Status: Recruiting
• Start date: October 2011
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Hospital Universitario de Valme
• Contact: Anais Corma-Gomez, MD
• Phone: 955015799
• Email: anais.corgo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy.

Methods:

Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients who fullfilled the following inclusion criteria are included in this study: 1) Have received a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of treatment.

Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a common protocol every six months. At every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. LS is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months.

Variables and data analysis: The primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. Predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a Cox regression for competitive risks applied to a developmental subpopulation. The performance of the model will be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1035
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Had achieved SVR 12 weeks after DAA-based regimen, either with or without Peg-interferon

• Showed liver stiffness (LS) value =9.5 kPa prior to treatment

• Had LS measurement available at SVR time-point

Exclusion Criteria:

• Individuals seropositive for HBsAg

• Individuals who refuse to participate

• Individuals under 18 years old

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Direct-acting Antivirals
• Hepatic Decompensation
• Hepatitis C
• Hepatitis C, Chronic
• Hepatocellular Carcinoma
• Sustained Virological Response

Locations

Country	Name	City	State
Spain	Hospital Universitario de Valme	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario de Valme	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver complications emergence	Appearance of hepatocellular carcinoma, portal hypertensive gastrointestinal bleeding, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorrenal syndrome and acute on chronic liver failure after SVR	From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)