Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs

Drug-Induced Liver Injury Clinical Trial

Official title:

Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602703
• Other study ID #: 17300211
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC

Description:

Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.

Radiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.

Blood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.

Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.

B and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.

Cell cycle analysis and apoptosis will be detected using Annexin V/PI staining method and flow cytometry analysis. The phosphorylation and activation of cytoplasmic proteins will be tested using Western blot analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with HCC on top of HCV related liver cirrhosis either received treatment or not

• Patients without HCC either received treatment or not .

• Patients with chronic HCV as a control group either received treatment or not.

Exclusion Criteria:

• Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc

• Patients with recurrent HCC after curative treatment.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chemical and Drug Induced Liver Injury
• Drug-Induced Liver Injury

Intervention

Diagnostic Test:
• Flow cytometry and Western Blot analysis
Diagnostic tests

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of immunity in patients with de novo HCC develped after treatment with DAAs	Difference of B and T cells immune responses after treatment with DAAs between those who develop HCC and those who do not develop HCC	Two months