Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone
NCT04710641
Adenocarcinoma, Blood-Borne Infections
Duarte, California, United States
View Trial DetailsNCT Number: NCT02025842
To evaluate the impact of liver fibrosis and other variables [e.g., age, sex, virological response (VR), and previous resistance to nucleoside/nucleotide analogue (NUC) therapy] on Hepatocellular carcinoma incidence in an Italian population of genotype D HBeAg-negative CHB patients treated with long-term NUC therapy.
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Notify Me18 year–75 year
All sexes
Observational
Hepatocellular carcinoma (HCC) usually develops in patients with chronic liver disease, particularly patients with liver cirrhosis. Chronic hepatitis B (CHB) is one of the most frequent underlying causes of HCC. Several studies have demonstrated that variations in the hepatitis B virus (HBV) genotype have different effects on HCC. HBV genotypes C and D had lower responses to interferon-based therapy and higher frequencies of basal core promoter mutations than genotypes A and B.For this reason, HBV genotypes C and D seem to lead to more severe liver disease, including cirrhosis, compared with the other HBV genotypes. Because liver cirrhosis is one of the strongest HCC risk factors in CHB patients, antiviral therapy may prevent the development of liver complications such as HCC. The aim of this study is to evaluate the impact of liver fibrosis and other variables, such as age, sex, virological response (VR), and resistance to nucleoside/nucleotide analogue (NUC) therapy, in a population of genotype D HBeAg-negative CHB patients treated with long-term NUC therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: follow-up of 62.5 months (range, 18 to 112 months),
The primary endpoint of the study was the development of Hepatocellular carcinoma. We assessed the risk of development of hepatocellular carcinoma according to liver status, viral response to treatment, and the presence of previous resistance to NUC therapy.
Time frame: follow-up of 62.5 months (range, 18 to 112 months),
survival in cirrhosis and chronic hepatitis B patients
Azienda Ospedaliera San Camillo Forlanini
Other
Long-term Nucleoside/Nucleotide Treatment of Hepatitis B Virus HBeAg-negative Genotype D Patients and Risk of Hepatocellular Carcinoma:Evidence From the CLEO Cohort Study
Acronym: HBV/HCC
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