Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase (PILOT)

December 21, 2022 updated by: Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Wu, M.D., Ph.D
  • Phone Number: 86-25-83105890
  • Email: dr.wu@nju.edu.cn

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213001
        • Recruiting
        • The Third Hospital of Changzhou
        • Contact:
          • Longgen Liu
      • Huai'an, Jiangsu, China, 223300
        • Recruiting
        • Huai'an No.4 People's Hospital
        • Contact:
          • Weimao Ding
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
        • Contact:
        • Contact:
      • Suqian, Jiangsu, China, 223800
        • Recruiting
        • Suqian People's Hospital
        • Contact:
          • Huaping Shao
      • Suzhou, Jiangsu, China, 215007
        • Recruiting
        • The Fifth People's Hospital of Suzhou
        • Contact:
          • Chuanwu Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HBeAg-negative chronic hepatitis B patients with indeterminate phase

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Coinfection with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus or human immunodeficiency virus;
  2. Coexisting of hepatocellular carcinoma and other malignancy, or alpha-fetoprotein >upper limit of normal at enrollment;
  3. Presence of liver cirrhosis;
  4. 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;
  5. Participating in other clinical trials in the last 3 months;
  6. Coexisting of autoimmune liver diseases;
  7. Pregnant or planned pregnancy in a short term or lactation patients;
  8. History of severe heart disease, mental disease;
  9. Uncontrolled diabetes, hypertension, thyroid dysfunction, retinopathy, autoimmune diseases;
  10. Neutrophil count <2×10^9/L and/or platelet count <100×10^9/L;
  11. History of organ transplantation or preparing for organ transplantation;
  12. Using immunosuppressive drugs;
  13. Undergone organ transplantation or preparing for organ transplantation;
  14. Receiving immunosuppressive agents;
  15. Patients thought by the investigators not suitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation cohort
Other: Observation
Monitor every 6 months
Treatment cohort
Other: Antiviral treatment
Receive first-line antiviral treatment, including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide or peginterferon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of hepatocellular carcinoma at 240 weeks
Time Frame: 240 weeks
240 weeks
The HBsAg clearance rate at 240 weeks
Time Frame: 240 weeks
240 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

February 1, 2028

Study Completion (Anticipated)

May 1, 2028

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Estimate)

December 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJDTID-2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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