Clinical trial · Observational
Risk of HCC in Cirrhotic Patients Post DAAs Ttt
Risk of Hepatocellular Carcinoma in HCV Cirrhotic Patients Treated With Direct Acting Antiviral Drugs.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HCV patients receiving DAAs
- description
- Patients with HCV-related liver cirrhosis (eligible for treatment) who will recieve DAAs therapy with one year follow up.markers: miR121, miR122, miR124will be assessed in both groups before and after DAAs
Primary outcomes (1)
- measure
- Occurrence and risk factors for HCC post DAAs
- timeFrame
- One year
- description
- Perecentage of occurrence of hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.
Secondary outcomes (1)
- measure
- Diagnostic value of miRNA in patients who developed HCC post DAAs
- timeFrame
- One Year
- description
- Measuring miRNA in patients who developed HCC post DAAs in mmol/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with HCV-related liver cirrhosis (eligible for treatment) who developed (HCC) after DAAs therapy within one year follow up. * Age and sex matched group of patients with HCV- related liver cirrhosis who didn't develop HCC after DAAs therapy within one year follow up(as control group) * Patients with chronic HCV related liver cirrhosis complicated by hepatocellular carcinoma not eligible for treatment.(discovered during enrollment in HCV treatment program) Exclusion Criteria: * Patients who refuse to participate in the study. * Patients with hepatitis B virus, any other causes of cirrhosis.(Alcohol consumpation, Biliary, Cardiac…..etc) * Patients with cancers other than HCC or metastatic liver cancer. * Patients who developed HCC on transplanted liver. * Patients who previously treated for HCC. * Patients who receive any immunosuppression drugs.
References
Publications (5)
- BACKGROUNDWartelle-Bladou C, Le Folgoc G, Bourliere M, Lecomte L. Hepatitis C therapy in non-genotype 1 patients: the near future. J Viral Hepat. 2012 Aug;19(8):525-36. doi: 10.1111/j.1365-2893.2012.01634.x. PMID 22762136
- BACKGROUNDXu J, Wu C, Che X, Wang L, Yu D, Zhang T, Huang L, Li H, Tan W, Wang C, Lin D. Circulating microRNAs, miR-21, miR-122, and miR-223, in patients with hepatocellular carcinoma or chronic hepatitis. Mol Carcinog. 2011 Feb;50(2):136-42. doi: 10.1002/mc.20712. Epub 2010 Dec 10. PMID 21229610
- BACKGROUNDPawlotsky JM, Feld JJ, Zeuzem S, Hoofnagle JH. From non-A, non-B hepatitis to hepatitis C virus cure. J Hepatol. 2015 Apr;62(1 Suppl):S87-99. doi: 10.1016/j.jhep.2015.02.006. PMID 25920094
- BACKGROUNDOmar A, Abou-Alfa GK, Khairy A, Omar H. Risk factors for developing hepatocellular carcinoma in Egypt. Chin Clin Oncol. 2013 Dec;2(4):43. doi: 10.3978/j.issn.2304-3865.2013.11.07. PMID 25841922
- BACKGROUNDLavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011 Feb;17(2):107-15. doi: 10.1111/j.1469-0691.2010.03432.x. PMID 21091831