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| Name | Class |
|---|---|
| Chinese Foundation for Hepatitis Prevention and Control | UNKNOWN |
| The Third People's Hospital of Taiyuan | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alpha based regimen | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| demographic characteristics | demographic characteristics at baseline | baseline |
Inclusion Criteria:
Exclusion Criteria:
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patients with chronic hepatitis B under anti-viral treatment of peginterferon alpha based regimen or nucleos(t)ide alone.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhong Zhang, Professor | Contact | 13801844344 | zhangwenhong@fudan.edu.cn | |
| Feng Sun, doctor | Contact | 15921403893 | aaronsf1125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenhong Zhang, MD | Huashan Hospital | Principal Investigator |
| Jiming Zhang, MD | Huashan Hospital | Principal Investigator |
| Feng Sun, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26231459 | Background | 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. | |
| 27374637 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2023 | Sep 30, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Beijing YouAn Hospital |
| OTHER |
| Henan Provincial People's Hospital | OTHER |
| Yunnan Provincial No.1 Hospital | UNKNOWN |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Beijing Ditan Hospital | OTHER |
| Tianjing No.2 People's Hospital | UNKNOWN |
| Qingdao No.6 People's Hospital | UNKNOWN |
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | OTHER |
| Ningbo Beilun District Traditional Chinese Medicine Hospital | OTHER |
| Wuxi No.5 People's Hospital | UNKNOWN |
| Taicang No.1 People's hospital | UNKNOWN |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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| nucleos(t)ide | Drug | 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 |
|
| 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 | 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 | 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. | 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. | 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 | 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. | 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. | 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. | 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 | 1year, 2 year, 3 year, 4 year and 5 year from baseline |
| Huashan Hospital |
| Study Chair |
| Qiran Zhang, MD | Huashan Hospital | Study Director |
| Shin 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. |
| 26048673 | Background | Nassal 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. |
| 29715359 | Background | Tang 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. |
| 30988907 | Background | 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. Clin Liver Dis (Hoboken). 2018 Aug 22;12(1):33-34. doi: 10.1002/cld.728. eCollection 2018 Jul. No abstract available. |
| 28427875 | Background | 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. |
| 26957439 | Background | Lim 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. |
| 29577029 | Background | Hu 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. |
| 24915612 | Background | Ning 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. |
| 32504662 | Background | Mak 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. |
| 30980394 | Background | Shiels 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. |
| 31634265 | Background | Hsu 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. |
| 19308310 | Background | Miyake 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. |
| 32077612 | Background | Shiffman 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. |
| 29753085 | Background | Jang 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. |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |