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Chronic Hepatitis bPILOTNCT05661786

Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

An observational study of Chronic Hepatitis b, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis b
What is being tested?
Observation and Antiviral treatment
How many people
4,500 participants
Where
5 sitesChina
Study dates
Dec 2022to May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HBeAg-negative chronic hepatitis B patients with indeterminate phase

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chao Wu, M.D., Ph.D contact

86-25-83105890

dr.wu@nju.edu.cn

Rui Huang, M.D., Ph.D contact

doctor_hr@126.com

5 sites in 1 country

China5 sites, 5 recruiting

  • The Third Hospital of Changzhou

    Changzhou, Jiangsu, 213001

    Longgen Liu

    Recruiting

  • Huai'an No.4 People's Hospital

    Huai'an, Jiangsu, 223300

    Weimao Ding

    Recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Chao Wu, M.D., Ph.D., 86-25-83105890, dr.wu@nju.edu.cn

    Rui Huang, M.D., Ph.D., doctor_hr@126.com

    Recruiting

  • Suqian People's Hospital

    Suqian, Jiangsu, 223800

    Huaping Shao

    Recruiting

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu, 215007

    Chuanwu Zhu

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Observation, Antiviral treatment
Keywords
Chronic hepatitis b, Indeterminate phase, hepatitis B surface antigen clearance, Hepatocellular carcinoma, Antiviral treatment
Medical subject headings
Hepatitis B, Chronic, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    Monitor every 6 months

  • Antiviral treatmentOther

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

Study groups in NCT05661786
Study groupRoleWhat they receive
Observation cohortNot described
Receives: Other: Observation
Treatment cohortNot described
Receives: Other: Antiviral treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of hepatocellular carcinoma at 240 weeks

    Measured: 240 weeks

  2. The HBsAg clearance rate at 240 weeks

    Measured: 240 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05661786
Sponsor's protocol ID
NJDTID-2201
Acronym
PILOT
Status last verified
Dec 2022
First submitted
13 Aug 2022
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ. 2019 Mar 1;97(3):230-238. doi: 10.2471/BLT.18.219469. Epub 2019 Jan 28.

    PubMed 30992636

  • Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.

    PubMed 29405329

  • Huang DQ, Li X, Le MH, Le AK, Yeo YH, Trinh HN, Zhang J, Li J, Wong C, Wong C, Cheung RC, Yang HI, Nguyen MH. Natural History and Hepatocellular Carcinoma Risk in Untreated Chronic Hepatitis B Patients With Indeterminate Phase. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1803-1812.e5. doi: 10.1016/j.cgh.2021.01.019. Epub 2021 Jan 16.

    PubMed 33465482

  • Yao K, Liu J, Wang J, Yan X, Xia J, Yang Y, Wu W, Liu Y, Chen Y, Zhang Z, Li J, Huang R, Wu C. Distribution and clinical characteristics of patients with chronic hepatitis B virus infection in the grey zone. J Viral Hepat. 2021 Jul;28(7):1025-1033. doi: 10.1111/jvh.13511. Epub 2021 Apr 26.

    PubMed 33797145

  • European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

    PubMed 28427875

  • Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH; REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006 Jan 4;295(1):65-73. doi: 10.1001/jama.295.1.65.

    PubMed 16391218

  • Bonacci M, Lens S, Marino Z, Londono MC, Rodriguez-Tajes S, Mas A, Garcia-Lopez M, Perez-Del-Pulgar S, Sanchez-Tapias JM, Forns X. Anti-viral therapy can be delayed or avoided in a significant proportion of HBeAg-negative Caucasian patients in the Grey Zone. Aliment Pharmacol Ther. 2018 May;47(10):1397-1408. doi: 10.1111/apt.14613. Epub 2018 Mar 25.

    PubMed 29577350

  • Choi GH, Kim GA, Choi J, Han S, Lim YS. High risk of clinical events in untreated HBeAg-negative chronic hepatitis B patients with high viral load and no significant ALT elevation. Aliment Pharmacol Ther. 2019 Jul;50(2):215-226. doi: 10.1111/apt.15311. Epub 2019 May 28.

    PubMed 31135074

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis b, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Wu, M.D., Ph.D (86-25-83105890, dr.wu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of hepatocellular carcinoma at 240 weeks (time frame: 240 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05661786, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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