Chronic Hepatitis bOASISNCT04896255
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
An observational study of Chronic Hepatitis b, run by Huashan Hospital at 1 site in China.
Trial summary
The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How… 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?
- peginterferon alpha based regimen and nucleos(t)ide
- How many people
- 33,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2020to 31 Dec 2031
- How long will I take part?
- 5 Years
- 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: patients with chronic hepatitis B under anti-viral treatment of peginterferon alpha based regimen or nucleos(t)ide alone.
Who may be able to join
- Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.
- There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.
- Planned or currently receiving potent low-resistance NAs [entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)], or planned to receive PegIFNα-2b, either treated or treatment-naïve.
- Agree to participate in the study and sign the patient informed consent form.
Who cannot join
- Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline
- Concurrently participating in other interventional clinical trials.
- Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Wenhong Zhang, Professor, 13801844344, zhangwenhong@fudan.edu.cn
Feng Sun, doctor, 15921403893, aaronsf1125@126.com
About this study
Official title: Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Multicenter, Real-world Study
The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How do rates of HBsAg seroclearance, decompensated cirrhosis, liver fibrosis progression, and other virological and clinical outcomes compare across regimens? Researchers will compare real-world treatment arms-including nucleos(t)ide analogue (NA) monotherapy (e.g., entecavir, tenofovir), PegIFN based regimen (e.g., PegIFN monotherapy, PegIFN plus NA combinations)-to identify optimal strategies for reducing HCC risk and improving functional cure rates.
Participants will undergo routine clinical care with no study-imposed interventions; data on demographics, medical history, symptoms, laboratory tests (e.g., HBsAg, HBV DNA, liver function), imaging (e.g., ultrasound, elastography), and clinical events will be collected prospectively (for up to 5 years in some cohorts) or retrospectively from medical records at baseline and scheduled follow-up visits (e.g., every 3-12 months initially, then annually).
Read the detailed description
The OASIS study is a multicenter, observational, real-world cohort study designed to evaluate long-term outcomes of antiviral therapies for chronic hepatitis B (CHB). It compares nucleos(t)ide analogue (NA) monotherapy, pegylated interferon based regimen without randomization or blinding. Treatment decisions follow routine clinical guidelines, physician expertise, and patient-specific factors. The study includes three cohorts: Prospective (PS, 5-year follow-up post-consent), Retrospective-Prospective (RPS, retrospective from baseline ≥September 2020 to consent, then 5-year prospective), and Retrospective (RS, data from September 2020 to protocol implementation). The target of 33,000 patients was determined based on patient flow across sub-centers, ensuring sufficient power to detect differences in 5-year HCC incidence (primary endpoint) and secondary outcomes (e.g., HBsAg seroclearance rates).
- Conditions
- Chronic Hepatitis b
- Being tested
- peginterferon alpha based regimen, nucleos(t)ide
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alpha based regimenDrug
peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
nucleos(t)ideDrug
peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
| Study group | Role | What they receive |
|---|---|---|
| Prospective | CHB patients enrolled pre-Protocol v3.0 (Dec 2023), planned or on antiviral therapy, followed prospectively for 5 years post-consent. Treatments: routine NA monotherapy, or PegIFN based regimens, per clinical guidelines. Data: baseline and 5 -year follow-up via routine visits. Receives: Drug: peginterferon alpha based regimen; Drug: nucleos(t)ide | |
| Retrospective-Prospective | CHB patients with baseline (≥Sep 2020) pre-v3.0, consenting post-v3.0. Retrospective data from baseline to consent; prospective for 5 years from baseline. Treatments: NAs monotherapy, or PegIFN based regimens. Data: retrospective before consent; prospective from visit matching baseline-consent interval. Missing routine data noted. Receives: Drug: peginterferon alpha based regimen; Drug: nucleos(t)ide | |
| Retrospective | CHB patients with records from Sep 2020 to v3.0 (Dec 2023), collected retrospectively. Treatments: NAs monotherapy, or PegIFN based regimens, per historical practice. Data: extracted from the electronic healthcare record; missing routine data recorded. Receives: Drug: peginterferon alpha based regimen; Drug: nucleos(t)ide |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of hepatocellular carcinoma at 5 year from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 5 years from baseline
Measured: 5 year from baseline
Secondary outcomes (10)
rate of HBsAg loss
rate of HBsAg loss will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of decompensated cirrhosis
Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease event at 1year, 2 year, 3 year, 4 year, and 5 year from baseline
Measured: 1year, 2 year, 3 year, 4 year and 5 year from baseline
rate of cirrhosis
rate of cirrhosis at 1 year, 2 year, 3 year, 4year, and 5 year from baseline
Measured: 1 year, 2 year, 3 year, 4year, and 5 year from baseline
rate of fibrosis progression
rate of fibrosis progression will be measured as a histological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of fibrosis regression
rate of fibrosis regression will be measured as a histological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of liver transplantation
Rate of liver transplantation will be evaluated as an end-stage liver disease event at 5 year from baseline
Measured: 5 year from baseline
HBsAg level
HBsAg level will be measured at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively, and kinetics will be described based on the results.
Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of HBeAg loss
rate of HBeAg loss will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of HBeAg conversion
rate of HBeAg conversion will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Measured: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of HBV DNA undetectable
Rate of HBV DNA undetectable will be evaluated as an end-stage liver disease event at 1year, 2 year, 3 year, 4 year, and 5 year from baseline
Measured: 1year, 2 year, 3 year, 4 year and 5 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start9 Sep 2020
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 33,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Foundation for Hepatitis Prevention and Control, The Third People's Hospital of Taiyuan, First Affiliated Hospital of Chongqing Medical University, Beijing YouAn Hospital, Henan Provincial People's Hospital, Yunnan Provincial No.1 Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xiamen University, Beijing Ditan Hospital, Tianjing No.2 People's Hospital, Qingdao No.6 People's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Ningbo Beilun District Traditional Chinese Medicine Hospital, Wuxi No.5 People's Hospital, Taicang No.1 People's hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, MD, Principal investigator, Huashan HospitalJiming Zhang, MD, Principal investigator, Huashan HospitalFeng Sun, MD, Study chair, Huashan HospitalQiran Zhang, MD, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896255
- Sponsor's protocol ID
- KY2020-911
- Acronym
- OASIS
- Status last verified
- Sep 2025
- First submitted
- 14 May 2021
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.
PubMed 26231459Shin EC, Sung PS, Park SH. Immune responses and immunopathology in acute and chronic viral hepatitis. Nat Rev Immunol. 2016 Aug;16(8):509-23. doi: 10.1038/nri.2016.69. Epub 2016 Jul 4.
PubMed 27374637Nassal M. HBV cccDNA: viral persistence reservoir and key obstacle for a cure of chronic hepatitis B. Gut. 2015 Dec;64(12):1972-84. doi: 10.1136/gutjnl-2015-309809. Epub 2015 Jun 5.
PubMed 26048673Tang LSY, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B Infection: A Review. JAMA. 2018 May 1;319(17):1802-1813. doi: 10.1001/jama.2018.3795.
PubMed 29715359Terrault 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. Clin Liver Dis (Hoboken). 2018 Aug 22;12(1):33-34. doi: 10.1002/cld.728. eCollection 2018 Jul. No abstract available.
PubMed 30988907European 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 28427875Lim TH, Gane E, Moyes C, Borman B, Cunningham C. HBsAg loss in a New Zealand community study with 28-year follow-up: rates, predictors and long-term outcomes. Hepatol Int. 2016 Sep;10(5):829-37. doi: 10.1007/s12072-016-9709-6. Epub 2016 Mar 8.
PubMed 26957439Hu P, Shang J, Zhang W, Gong G, Li Y, Chen X, Jiang J, Xie Q, Dou X, Sun Y, Li Y, Liu Y, Liu G, Mao D, Chi X, Tang H, Li X, Xie Y, Chen X, Jiang J, Zhao P, Hou J, Gao Z, Fan H, Ding J, Zhang D, Ren H. HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study. J Clin Transl Hepatol. 2018 Mar 28;6(1):25-34. doi: 10.14218/JCTH.2017.00072. Epub 2018 Mar 17.
PubMed 29577029Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
PubMed 24915612Mak LY, Wong DK, Pollicino T, Raimondo G, Hollinger FB, Yuen MF. Occult hepatitis B infection and hepatocellular carcinoma: Epidemiology, virology, hepatocarcinogenesis and clinical significance. J Hepatol. 2020 Oct;73(4):952-964. doi: 10.1016/j.jhep.2020.05.042. Epub 2020 Jun 3.
PubMed 32504662Shiels MS, Engels EA, Yanik EL, McGlynn KA, Pfeiffer RM, O'Brien TR. Incidence of hepatocellular carcinoma among older Americans attributable to hepatitis C and hepatitis B: 2001 through 2013. Cancer. 2019 Aug 1;125(15):2621-2630. doi: 10.1002/cncr.32129. Epub 2019 Apr 12.
PubMed 30980394Hsu YC, Wong GL, Chen CH, Peng CY, Yeh ML, Cheung KS, Toyoda H, Huang CF, Trinh H, Xie Q, Enomoto M, Liu L, Yasuda S, Tanaka Y, Kozuka R, Tsai PC, Huang YT, Wong C, Huang R, Jang TY, Hoang J, Yang HI, Li J, Lee DH, Takahashi H, Zhang JQ, Ogawa E, Zhao C, Liu C, Furusyo N, Eguchi Y, Wong C, Wu C, Kumada T, Yuen MF, Yu ML, Nguyen MH. Tenofovir Versus Entecavir for Hepatocellular Carcinoma Prevention in an International Consortium of Chronic Hepatitis B. Am J Gastroenterol. 2020 Feb;115(2):271-280. doi: 10.14309/ajg.0000000000000428.
PubMed 31634265Miyake Y, Kobashi H, Yamamoto K. Meta-analysis: the effect of interferon on development of hepatocellular carcinoma in patients with chronic hepatitis B virus infection. J Gastroenterol. 2009;44(5):470-5. doi: 10.1007/s00535-009-0024-z. Epub 2009 Mar 25.
PubMed 19308310Shiffman ML. Approach to the patient with chronic hepatitis B and decompensated cirrhosis. Liver Int. 2020 Feb;40 Suppl 1:22-26. doi: 10.1111/liv.14359.
PubMed 32077612Jang JW, Choi JY, Kim YS, Yoo JJ, Woo HY, Choi SK, Jun CH, Lee CH, Sohn JH, Tak WY, Lee YR, Han KH. Effects of Virologic Response to Treatment on Short- and Long-term Outcomes of Patients With Chronic Hepatitis B Virus Infection and Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1954-1963.e3. doi: 10.1016/j.cgh.2018.04.063. Epub 2018 May 9.
PubMed 29753085
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Multicenter, Real-world Study
- ClinicalTrials.gov ID
- NCT04896255
- Acronym / sponsor ID
- OASIS / KY2020-911
- Conditions
- Chronic Hepatitis b
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Chinese Foundation for Hepatitis Prevention and Control, The Third People's Hospital of Taiyuan, First Affiliated Hospital of Chongqing Medical University, Beijing YouAn Hospital, Henan Provincial People's Hospital, Yunnan Provincial No.1 Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xiamen University, Beijing Ditan Hospital, Tianjing No.2 People's Hospital, Qingdao No.6 People's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Ningbo Beilun District Traditional Chinese Medicine Hospital, Wuxi No.5 People's Hospital, Taicang No.1 People's hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How do rates of HBsAg seroclearance, decompensated cirrhosis, liver fibrosis progression, and other virological and clinical outcomes compare across regimens? Researchers will compare real-world treatment arms-including nucleos(t)ide analogue (NA) monotherapy (e.g., entecavir, tenofovir), PegIFN based regimen (e.g., PegIFN monotherapy, PegIFN plus NA combinations)-to identify optimal strategies for reducing HCC risk and improving functional cure rates.
Participants will undergo routine clinical care with no study-imposed interventions; data on demographics, medical history, symptoms, laboratory tests (e.g., HBsAg, HBV DNA, liver function), imaging (e.g., ultrasound, elastography), and clinical events will be collected prospectively (for up to 5 years in some cohorts) or retrospectively from medical records at baseline and scheduled follow-up visits (e.g., every 3-12 months initially, then annually).
Detailed description
The OASIS study is a multicenter, observational, real-world cohort study designed to evaluate long-term outcomes of antiviral therapies for chronic hepatitis B (CHB). It compares nucleos(t)ide analogue (NA) monotherapy, pegylated interferon based regimen without randomization or blinding. Treatment decisions follow routine clinical guidelines, physician expertise, and patient-specific factors. The study includes three cohorts: Prospective (PS, 5-year follow-up post-consent), Retrospective-Prospective (RPS, retrospective from baseline ≥September 2020 to consent, then 5-year prospective), and Retrospective (RS, data from September 2020 to protocol implementation). The target of 33,000 patients was determined based on patient flow across sub-centers, ensuring sufficient power to detect differences in 5-year HCC incidence (primary endpoint) and secondary outcomes (e.g., HBsAg seroclearance rates).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Drug: peginterferon alpha based regimen, Drug: nucleos(t)ideCHB patients enrolled pre-Protocol v3.0 (Dec 2023), planned or on antiviral therapy, followed prospectively for 5 years post-consent. Treatments: routine NA monotherapy, or PegIFN based regimens, per clinical guidelines. Data: baseline and 5 -year follow-up via routine visits. |
| Retrospective-Prospective | – | Drug: peginterferon alpha based regimen, Drug: nucleos(t)ideCHB patients with baseline (≥Sep 2020) pre-v3.0, consenting post-v3.0. Retrospective data from baseline to consent; prospective for 5 years from baseline. Treatments: NAs monotherapy, or PegIFN based regimens. Data: retrospective before consent; prospective from visit matching baseline-consent interval. Missing routine data noted. |
| Retrospective | – | Drug: peginterferon alpha based regimen, Drug: nucleos(t)ideCHB patients with records from Sep 2020 to v3.0 (Dec 2023), collected retrospectively. Treatments: NAs monotherapy, or PegIFN based regimens, per historical practice. Data: extracted from the electronic healthcare record; missing routine data recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic hepatitis B under anti-viral treatment of peginterferon alpha based regimen or nucleos(t)ide alone.
Key inclusion criteria (4 listed)
- Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.
- There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.
- Planned or currently receiving potent low-resistance NAs [entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)], or planned to receive PegIFNα-2b, either treated or treatment-naïve.
- Agree to participate in the study and sign the patient informed consent form.
Key exclusion criteria (3 listed)
- Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline
- Concurrently participating in other interventional clinical trials.
- Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon alpha based regimenpeginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study | Drug | Prospective, Retrospective, Retrospective-Prospective |
| nucleos(t)idepeginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study | Drug | Prospective, Retrospective, Retrospective-Prospective |
Primary outcome
rate of hepatocellular carcinoma at 5 year from baseline
Time frame: 5 year from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 5 years from baseline
10 secondary outcomes
rate of HBsAg loss
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of decompensated cirrhosis
Time frame: 1year, 2 year, 3 year, 4 year and 5 year from baseline
rate of cirrhosis
Time frame: 1 year, 2 year, 3 year, 4year, and 5 year from baseline
rate of fibrosis progression
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of fibrosis regression
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of liver transplantation
Time frame: 5 year from baseline
HBsAg level
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of HBeAg loss
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of HBeAg conversion
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
rate of HBV DNA undetectable
Time frame: 1year, 2 year, 3 year, 4 year and 5 year from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 26231459Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.
- Background: PubMed 27374637Shin EC, Sung PS, Park SH. Immune responses and immunopathology in acute and chronic viral hepatitis. Nat Rev Immunol. 2016 Aug;16(8):509-23. doi: 10.1038/nri.2016.69. Epub 2016 Jul 4.
- Background: PubMed 26048673Nassal M. HBV cccDNA: viral persistence reservoir and key obstacle for a cure of chronic hepatitis B. Gut. 2015 Dec;64(12):1972-84. doi: 10.1136/gutjnl-2015-309809. Epub 2015 Jun 5.
- Background: PubMed 29715359Tang LSY, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B Infection: A Review. JAMA. 2018 May 1;319(17):1802-1813. doi: 10.1001/jama.2018.3795.
- Background: PubMed 30988907Terrault 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. Clin Liver Dis (Hoboken). 2018 Aug 22;12(1):33-34. doi: 10.1002/cld.728. eCollection 2018 Jul. No abstract available.
- Background: PubMed 28427875European 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.
- Background: PubMed 26957439Lim TH, Gane E, Moyes C, Borman B, Cunningham C. HBsAg loss in a New Zealand community study with 28-year follow-up: rates, predictors and long-term outcomes. Hepatol Int. 2016 Sep;10(5):829-37. doi: 10.1007/s12072-016-9709-6. Epub 2016 Mar 8.
- Background: PubMed 29577029Hu P, Shang J, Zhang W, Gong G, Li Y, Chen X, Jiang J, Xie Q, Dou X, Sun Y, Li Y, Liu Y, Liu G, Mao D, Chi X, Tang H, Li X, Xie Y, Chen X, Jiang J, Zhao P, Hou J, Gao Z, Fan H, Ding J, Zhang D, Ren H. HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study. J Clin Transl Hepatol. 2018 Mar 28;6(1):25-34. doi: 10.14218/JCTH.2017.00072. Epub 2018 Mar 17.
- Background: PubMed 24915612Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
- Background: PubMed 32504662Mak LY, Wong DK, Pollicino T, Raimondo G, Hollinger FB, Yuen MF. Occult hepatitis B infection and hepatocellular carcinoma: Epidemiology, virology, hepatocarcinogenesis and clinical significance. J Hepatol. 2020 Oct;73(4):952-964. doi: 10.1016/j.jhep.2020.05.042. Epub 2020 Jun 3.
- Background: PubMed 30980394Shiels MS, Engels EA, Yanik EL, McGlynn KA, Pfeiffer RM, O'Brien TR. Incidence of hepatocellular carcinoma among older Americans attributable to hepatitis C and hepatitis B: 2001 through 2013. Cancer. 2019 Aug 1;125(15):2621-2630. doi: 10.1002/cncr.32129. Epub 2019 Apr 12.
- Background: PubMed 31634265Hsu YC, Wong GL, Chen CH, Peng CY, Yeh ML, Cheung KS, Toyoda H, Huang CF, Trinh H, Xie Q, Enomoto M, Liu L, Yasuda S, Tanaka Y, Kozuka R, Tsai PC, Huang YT, Wong C, Huang R, Jang TY, Hoang J, Yang HI, Li J, Lee DH, Takahashi H, Zhang JQ, Ogawa E, Zhao C, Liu C, Furusyo N, Eguchi Y, Wong C, Wu C, Kumada T, Yuen MF, Yu ML, Nguyen MH. Tenofovir Versus Entecavir for Hepatocellular Carcinoma Prevention in an International Consortium of Chronic Hepatitis B. Am J Gastroenterol. 2020 Feb;115(2):271-280. doi: 10.14309/ajg.0000000000000428.
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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenhong Zhang, MD principal investigator
Huashan Hospital
Jiming Zhang, MD principal investigator
Huashan Hospital
Feng Sun, MD study chair
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b, run by Huashan Hospital at 1 site 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 4 inclusion and 3 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wenhong Zhang, Professor (13801844344, zhangwenhong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of hepatocellular carcinoma at 5 year from baseline (time frame: 5 year from baseline). 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 NCT04896255, which also lists 15 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 6 Oct 2025.