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

NCT02025842 | Completed DMC

• 1 other identifier: 02
• Study Type: observational
• Target: 306
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Hepatitis B

Keywords

Hepatocellular carcinoma; Hepatitis B

Outcome Measures

Primary Outcomes (1)

• risk for hepatocellular carcinoma

  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.

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

Secondary Outcomes (1)

• survival

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

Study Arms (2)

Chronic hepatitis B patients

Chronic hepatitis B patients treated with nucleoside/nucleotide

Compensated cirrhosis patients

Compensated cirrhosis patients treated with nucleoside/nucleotide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From January 2000 to December 2013, 745 HBV-infected patients were included in the database. Of these, 438 were excluded: 226 did not fulfil the diagnosis of CHB, 75 had HBeAg-positive CHB, 20 had received NUC for \<18 months, 26 had HCC diagnosed before or within the first 18 months of therapy, and 61 presented a different HBV genotype. Thirty patients had decompensated cirrhosis. A total of 306 HBeAg-negative genotype D patients were selected and included in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera San Camillo Forlanini: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• Adriano M Pellicelli, MD

  AO San Camillo Forlanini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 62 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Study Start: January 1, 2000
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 1, 2014

Record last verified: 2013-12