Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .

Cirrhosis Clinical Trial

Official title:

Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03084185
• Other study ID #: HVPG_HCV
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2017
• Last updated: September 12, 2017
• Start date: December 2012
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: University of Modena and Reggio Emilia
• Contact: ERICA VILLA, MD
• Phone: +39 0594225308
• Email: erica.villa[@]unimore.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients.

The duration of the study is 36 months and it provides a cohort of 200 patients.

Description:

At screening, patient will have taken blood samples and performed hepatic vein pressure gradient.

After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines.

In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of liver cirrhosis

• Aged between 18 and 75 years

• Obtaining written informed consent

• Absence of exclusion criteria

Exclusion Criteria:

• Diagnosis of hepatocellular carcinoma

• Presence of portal vein thrombosis

• HIV

• Liver transplantation

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Policlinico Di Modena	Modena	MO

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.	Patients will be subject to blood sample periodically and following exams will be made: Chemistry and hematology to define liver function; Intestinal Fatty Acid Binding Protein; 16S, ribosomal deoxyribonucleic acid; Cluster of differentiation 14; Interleukin 6; Asymmetrical dimethylarginine; Tissue factor; According to current guidelines, patients will be submitted to: Hepatic vein pressure gradient AND combined right heart catheterization; Liver elastography	December 2018
Secondary	Finding of serum metabolomic features of cirrhotic patients.	Analysis will be conducted on sera collected during the screening and every three months. These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software	December 2018