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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Third Hospital of Changzhou
RECRUITING
Changzhou
Huai'an No.4 People's Hospital
RECRUITING
Huai'an
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Suqian People's Hospital
RECRUITING
Suqian
The Fifth People's Hospital of Suzhou
RECRUITING
Suzhou
Contact Information
Primary
Chao Wu, M.D., Ph.D
dr.wu@nju.edu.cn
86-25-83105890
Backup
Rui Huang, M.D., Ph.D
doctor_hr@126.com
Time Frame
Start Date: 2022-12
Estimated Completion Date: 2028-05
Participants
Target number of participants: 4500
Treatments
Observation cohort
Treatment cohort
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov