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NCT Number: NCT04896255

Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B

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).

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 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.

  2. rate of decompensated cirrhosis

    Time frame: 1year, 2 year, 3 year, 4 year and 5 year from baseline

    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

  3. rate of cirrhosis

    Time frame: 1 year, 2 year, 3 year, 4year, and 5 year from baseline

    rate of cirrhosis at 1 year, 2 year, 3 year, 4year, and 5 year from baseline

  4. 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 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.

  5. 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 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.

  6. rate of liver transplantation

    Time frame: 5 year from baseline

    Rate of liver transplantation will be evaluated as an end-stage liver disease event at 5 year from baseline

  7. 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

    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.

  8. 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 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.

  9. 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 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.

  10. rate of HBV DNA undetectable

    Time frame: 1year, 2 year, 3 year, 4 year and 5 year from baseline

    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

Other outcomes

  1. demographic characteristics

    Time frame: baseline

    demographic characteristics at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Sun, doctor

CONTACT

[email protected]

15921403893

Wenhong Zhang, Professor

CONTACT

[email protected]

13801844344

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing YouAn Hospital
  • Chinese Foundation for Hepatitis Prevention and Control
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Chongqing Medical University
  • Henan Provincial People's Hospital
  • Ningbo Beilun District Traditional Chinese Medicine Hospital
  • Qingdao No.6 People's Hospital
  • Taicang No.1 People's hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Xiamen University
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  • The Third People's Hospital of Taiyuan
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Tianjing No.2 People's Hospital
  • Wuxi No.5 People's Hospital
  • Yunnan Provincial No.1 Hospital

Registry information

Official study title

Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Multicenter, Real-world Study

Acronym: OASIS

Important dates

Study start
2020
Primary completion
2026
Study completion
2031
First posted
May 21, 2021
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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