NCT05661786Recruiting
Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase
Clinical Outcomes of HBeAg-negative Chronic Hepatitis B Patients With Indeterminate Phase: a Multi-center, Prospective, Observational Cohort Study (PILOT)
Source: ClinicalTrials.gov · Last updated 22 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4500 (estimated)
- First submitted
- 13 Aug 2022
- Start date
- Dec 2022
- Primary completion date
- Feb 2028
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- NCT number
- NCT05661786
What you commit to
- Study type: Observational
- Planned participants: 4500
- From Dec 2022 to the primary completion date, Feb 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Using immunosuppressive drugs;
- Undergone organ transplantation or preparing for organ transplantation;
- Receiving immunosuppressive agents;
Other illness
- 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;
- Coexisting of autoimmune liver diseases;
- History of severe heart disease, mental disease;
- Uncontrolled diabetes, hypertension, thyroid dysfunction, retinopathy, autoimmune diseases;
- History of organ transplantation or preparing for organ transplantation;
Lab values
- Neutrophil count \<2×10\^9/L and/or platelet count \<100×10\^9/L;
Other
- Presence of liver cirrhosis;
- Participating in other clinical trials in the last 3 months;
- Pregnant or planned pregnancy in a short term or lactation patients;
- Patients thought by the investigators not suitable to participate in this study.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Huai'an No.4 People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Suqian People's Hospital Coordinator of this site? Confirm its status | Suqian | China | Recruiting |
| The Fifth People's Hospital of Suzhou Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.