Actively Recruiting
Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2022-12-22
4500
Participants Needed
5
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hepatitis B surface antigen (HBsAg) positive over 6 months
- Age 18 years or older
- Treatment-naïve for hepatitis B
- HBeAg negative and anti-HBe positive
- HBV DNA greater than 2000 IU/mL
- Persistently normal alanine transaminase (ALT) levels
- Liver inflammation less than G2 or A2 and liver fibrosis less than S2 or F2 before enrollment, or liver stiffness greater than 8 kilopascals (kPa)
- No family history of liver cirrhosis or hepatocellular carcinoma
You will not qualify if you...
- Coinfection with hepatitis A, C, D, E virus or HIV
- Presence of hepatocellular carcinoma or other cancers, or alpha-fetoprotein above normal at enrollment
- Presence of liver cirrhosis
- Alcohol abuse within the last year (men over 40 g/day, women over 20 g/day) or heavy drinking within 2 weeks before enrollment (over 80 g/day), or drug abuse history
- Participation in other clinical trials in the last 3 months
- Coexisting autoimmune liver diseases
- Pregnancy, planned pregnancy soon, or breastfeeding
- History of severe heart disease or mental illness
- Uncontrolled diabetes, hypertension, thyroid problems, retinopathy, or autoimmune diseases
- Low neutrophil count (<2 x 10^9/L) or low platelet count (<100 x 10^9/L)
- History of or preparing for organ transplantation
- Use of immunosuppressive drugs
- Considered unsuitable for the study by investigators
AI-Screening
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Trial Site Locations
Total: 5 locations
1
The Third Hospital of Changzhou
Changzhou, Jiangsu, China, 213001
Actively Recruiting
2
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, China, 223300
Actively Recruiting
3
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
4
Suqian People's Hospital
Suqian, Jiangsu, China, 223800
Actively Recruiting
5
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China, 215007
Actively Recruiting
Research Team
C
Chao Wu, M.D., Ph.D
CONTACT
R
Rui Huang, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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