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Completed

NCT Number: NCT02025842

Hepatitis B Virus HBeAg-negative Genotype D Patients and Hepatocellular Carcinoma

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Only chronic hepatitis B or compensated cirrhosis HBeAg-negative genotype D patients were included in this study.The patients were included in this study if they were ≥18 years old and had received treatment with nucleoside/nucleotide for a period of at least 18 months.

Exclusion criteria

  • Patients with Hepatocellular carcinoma diagnosed before or during the first 18 months of nucleoside/nucleotide therapy, as well as patients coinfected with hepatitis D, hepatitis C, or HIV, were excluded. Patients with decompensated cirrhosis were excluded because of the low number of cases observed.

Treatment and study plan

Primary outcomes

  1. risk for hepatocellular carcinoma

    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.

Secondary outcomes

  1. survival

    Time frame: follow-up of 62.5 months (range, 18 to 112 months),

    survival in cirrhosis and chronic hepatitis B patients

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Camillo Forlanini

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2013
Study completion
2013
First posted
Jan 1, 2014
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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