Clinical Trials Logo

Clinical Trial Summary

Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. This type of treatment has now completely replaced interferon-based therapy .Therapy of chronic hepatitis C with direct-acting antivirals (DAAs) is able to induce a sustained virological response (SVR) in over 85% of patients, even if liver cirrhosis is present. Cirrhotic patients should be closely monitored after treatment.HCC is thought to develop over time as the liver is exposed to inflammation and develops fibrosis. Thus, if DAAs can eliminate inflammation mediated by HCV, the risk of HCC should decrease. However, several centers have observed that this actually may not be the case. Tumor genesis occurs through a multistep, multifactorial process. Eliminating HCV-induced inflammation may not be enough to decrease risk of HCC.DAAs have provided an effective, well tolerated treatment for hepatitis C in patents with cirrhosis . However, several studies have shown unexpectedly high rates of recurrence of HCC in the early post DAAs treatment time period.

1. Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.

2. To asses diagnostic value of novel markers in patients who developed hepatocellular carcinoma (HCC) after (DAAs)


Clinical Trial Description

HCV is a worldwide infection, it is estimated that about at about 3.0% (170-200 million people) of the world's population are infected. HCV is associated with an increased disease burden due to liver cirrhosis and considerable mortality . More than 350,000 people dying each year from hepatitis C-related liver disease. Adding to the problem of HCV infection is the presence of occult HCV infection.

Egypt has the highest prevalence worldwide, it is estimated to be 14.7% among a representative sample of Egyptian population, aged 15-59 year . Egypt is among countries responsible for 80.0% of global infections. Further, prevalence is higher among hospitalized patients and special clinical populations.

Hepatitis C virus (HCV) has great genetic variability, with 6 major genotypes (GTs); GT-1 to 6. In Egypt, HCV is almost exclusive GT-4 distribution. HCV has significant differences in their global distribution and prevalence.

Worldwide, Hepatocellular carcinoma (HCC) is the fifth most common cancer in men and the seventh in women. Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death worldwide and one of the leading causes of death among patients with cirrhosis. In Egypt, HCC is the second most common cancer in men and the sixth most common cancer in women.

Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. This type of treatment has now completely replaced interferon-based therapy .Therapy of chronic hepatitis C with direct-acting antivirals (DAAs) is able to induce a sustained virological response (SVR) in over 85% of patients, even if liver cirrhosis is present. Cirrhotic patients should be closely monitored after treatment.

HCC is thought to develop over time as the liver is exposed to inflammation and develops fibrosis. Thus, if DAAs can eliminate inflammation mediated by HCV, the risk of HCC should decrease. However, several centers have observed that this actually may not be the case. Tumor genesis occurs through a multistep, multifactorial process. Eliminating HCV-induced inflammation may not be enough to decrease risk of HCC.

DAAs have provided an effective, well tolerated treatment for hepatitis C in patents with cirrhosis. However, several studies have shown unexpectedly high rates of recurrence of HCC in the early post DAAs treatment time period.

MicroRNAs (miRNAs) are a set of small, single-stranded, non-coding RNA molecules (21-30 nucleotides) that negatively regulate gene expression at the posttranscriptional level by translational inhibition or degradation of target mRNA, depending on the degree of complementary base pairing. Aberrant expression of miRNA is common in various human malignancies and modulates cancer-associated genomic regions or fragile sites. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues. However, little is known about the mechanisms of miRNA-related cell proliferation and development.ref

Aim of work:

1. Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.

2. To asses diagnostic value of novel markers in patients who developed hepatocellular carcinoma (HCC) after direct acting antiviral drugs -DAAs -therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03414554
Study type Observational
Source Assiut University
Contact Alshaimaa Rafat, MD
Phone 01004206006
Email shosho_rafat@yahoo.com
Status Not yet recruiting
Phase N/A
Start date February 1, 2018
Completion date February 28, 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05458115 - Clinical Study of MRD Recurrence Monitoring After Surgical Resection of Hepatocellular Carcinoma
Not yet recruiting NCT05022628 - Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis Phase 4
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Not yet recruiting NCT06434480 - SBRT in HCC With Oligoprogression on Atezo-Bev N/A
Completed NCT04542837 - The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma Phase 2
Not yet recruiting NCT05025592 - cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
Completed NCT04172506 - A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT05840133 - Study of Long Non-coding RNA SNHG15 as a Novel Biomarker in HBV Associated HCC
Not yet recruiting NCT06024252 - Efficacy, Safety, and Treatment Patterns of Transcatheter Arterial Chemoembolization (TACE) Combined With Atezolizumab and Bevacizumab in Unresectable Hepatocellular Carcinoma: a Multicenter, Retrospective, Observational Real-world Study
Terminated NCT02785874 - Statin With Palliative Therapy for HCC N/A
Not yet recruiting NCT02715492 - Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma. Phase 3
Completed NCT02985034 - Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT N/A
Not yet recruiting NCT06069947 - SALT for Liver Cirrhosis With HCC N/A
Recruiting NCT05581004 - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Suspended NCT02935478 - Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation N/A
Recruiting NCT05592171 - Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCC N/A
Completed NCT03176485 - Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors N/A
Recruiting NCT05544253 - Safety and Efficacy of Mitomycin C-based HIPEC After srHCC and PM of HCC Phase 2/Phase 3
Recruiting NCT06184152 - CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
Completed NCT02675920 - A Study of HCC High Risk Group Using Two Surveillance Tools