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

May 20, 2021 updated by: Wen-hong Zhang, Huashan Hospital

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

This is a multicenter, prospective, real-world study, recruiting patients with chronic hepatitis B under anti-viral treatment. The recruited participants will receive peginterferon alpha based regimen or nucleos(t)ide alone. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc）of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment. The follow-up time course of this study will be 5 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be allocated into two cohorts based on the anti-viral treatment decided by their doctors. If they are going to take peginterferon alpha based regimen, they will be allocated in interferon cohort. If they are going to take nucleos(t)ide alone, they will be allocated in nucleos(t)ide cohort. The follow-up plan will be made by their doctors according to their conditions. No extra intervention or examination will be given in this study. The primary outcome is end-stage liver diseases including hepatocellular carcinoma and decompensated cirrhosis, and the rate of hepatocellular carcinoma and decompensated cirrhosis will be measure at 1 year，2 years，3 years, 4 years and 5 years from baseline. Secondary events including HBsAg loss, HBeAg conversion, fibrosis progression and fibrosis, which 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. Results of laboratory testings will be recorded at each follow-up visit. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc）of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment.

Study Type

Observational

Enrollment (Anticipated)

20000

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

Study Contact Backup

Study Locations

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic hepatitis B under anti-viral treatment of peginterferon alpha based regimen or nucleos(t)ide alone.

Description

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 to receive or already receiving anti-viral treatment with nucleos(t)ide including Entecavir, Tenofovir, and Tenofoviralafenamide. Or planned to receive peginterferon alpha 2b, either treated or treatment-naive.
  • Agree to participate in the study and sign the patient informed consent form.

Exclusion Criteria:

  • Currently treatment-related participating clinical trials.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
interferon cohort
Patients who are going to take peginterferon alpha based regimen
Drug: peginterferon alpha based regimen
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 cohort
Patients who are going to take nucleos(t)ide alone
Drug: nucleos(t)ide
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of hepatocellular carcinoma at 1 year from baseline
Time Frame: 1 year from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 1 year，2 years，3 years, 4 years and 5 years from baseline
1 year from baseline
rate of hepatocellular carcinoma at 3 years from baseline
Time Frame: 3 years from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 1 year，2 years，3 years, 4 years and 5 years from baseline
3 years from baseline
rate of hepatocellular carcinoma at 3 years from baseline
Time Frame: 5 years from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 1 year，2 years，3 years, 4 years and 5 years from baseline
5 years from baseline
rate of decompensated cirrhosis at 1 year from baseline
Time Frame: 1 year from baseline
Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease event at 1 year，2 years，3 years, 4 years and 5 years from baseline
1 year from baseline
rate of decompensated cirrhosis at 3 years from baseline
Time Frame: 3 years from baseline
Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease
3 years from baseline
rate of decompensated cirrhosis at 5 years from baseline
Time Frame: 5 years from baseline
Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease
5 years from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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
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.
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
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.
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 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
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.
24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline

Collaborators and Investigators

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

Sponsor

Huashan Hospital

Collaborators

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

Investigators

  • Principal Investigator: Wenhong Zhang, MD, Huashan Hospital
  • Principal Investigator: Jiming Zhang, MD, Huashan Hospital
  • Study Chair: Feng Sun, MD, Huashan Hospital
  • Study Director: Qiran Zhang, MD, Huashan Hospital

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)

May 10, 2021

Primary Completion (ANTICIPATED)

July 25, 2025

Study Completion (ANTICIPATED)

July 25, 2030

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (ACTUAL)

May 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2020-911

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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