Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

Chronic hepatitis B virus (HBV) infection remains a global public health burden around the world. Investigating the disease process of chronic hepatitis B (CHB) is essential to individual management in clinical practice. According to American Association for the Study of Liver Diseases (AASLD) 2018 Hepatitis B Guidance, CHB can be classified into four phases: immune-tolerant CHB, HBeAg-positive immune active CHB, inactive CHB and hepatitis B e antigen (HBeAg)-negative immune active CHB. Antiviral therapy is recommended in patients with HBeAg-positive or -negative immune active CHB patients to reduce the incidence of liver cirrhosis and hepatocellular carcinoma, while periodic monitoring is recommended for inactive carrier and immune-tolerant CHB patients. However, a substantial proportion of patients fall into an indeterminate phase whose serum HBV DNA and alanine aminotransferase levels do not fit well into these well-described phases. Most of CHB patients with indeterminate phase are HBeAg negative. However, the clinical outcomes of these patients remain unclear. Therefore, the purpose of this study is to investigate the clinical outcomes of HBeAg-negative chronic hepatitis B patients with indeterminate phase.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Hepatitis B Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Hospital of Changzhou, Changzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Hepatitis B surface antigen (HBsAg) positive over 6 months
Age ≥18 years
Treatment-naïve
HBeAg negative, anti-HBe positive
HBV DNA >2000 IU/mL
Persistently normal alanine transaminase (ALT)
Liver inflammation <G2 or A2 and liver fibrosis <S2 or F2 before enrollment, or liver stiffness >8 kilopascals (kPa)
No family history of liver cirrhosis or hepatocellular carcinoma

Exclusion criteria

Coinfection with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus or human immunodeficiency virus;
Coexisting of hepatocellular carcinoma and other malignancy, or alpha-fetoprotein >upper limit of normal at enrollment;
Presence of liver cirrhosis;
Alcohol abuse within the last year (ethanol: male >40 g/d, female >20 g/d; or heavy drinking within 2 weeks before enrollment: ethanol >80 g/d), or history of drug abuse;
Participating in other clinical trials in the last 3 months;
Coexisting of autoimmune liver diseases;
Pregnant or planned pregnancy in a short term or lactation patients;
History of severe heart disease, mental disease;
Uncontrolled diabetes, hypertension, thyroid dysfunction, retinopathy, autoimmune diseases;
Neutrophil count <2×10^9/L and/or platelet count <100×10^9/L;
History of organ transplantation or preparing for organ transplantation;
Using immunosuppressive drugs;
Undergone organ transplantation or preparing for organ transplantation;
Receiving immunosuppressive agents;
Patients thought by the investigators not suitable to participate in this study.

Treatment and study plan

observation

Other

Monitor every 6 months

Antiviral treatment

Other

Receive first-line antiviral treatment, including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide or peginterferon

Primary outcomes

The incidence of hepatocellular carcinoma at 240 weeks

Time frame: 240 weeks
The HBsAg clearance rate at 240 weeks

Time frame: 240 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Wu, M.D., Ph.D

CONTACT

[email protected]

86-25-83105890

Rui Huang, M.D., Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

Clinical Outcomes of HBeAg-negative Chronic Hepatitis B Patients With Indeterminate Phase: a Multi-center, Prospective, Observational Cohort Study (PILOT)

Acronym: PILOT

Important dates

Study start: 2022
Primary completion: 2028
Study completion: 2028
First posted: Dec 22, 2022
Registry last updated: Dec 22, 2022

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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting