Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B (OASIS)
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| ClinicalTrials.gov Identifier: NCT04896255 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2021
Last Update Posted : May 21, 2021
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Sponsor:
Huashan Hospital
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
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital
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Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Hepatitis b | Drug: peginterferon alpha based regimen Drug: nucleos(t)ide |
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 [Patient Registry] |
| Estimated Enrollment : | 20000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Prospective, Multicenter, Real-world Study |
| Estimated Study Start Date : | May 10, 2021 |
| Estimated Primary Completion Date : | July 25, 2025 |
| Estimated Study Completion Date : | July 25, 2030 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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interferon cohort
Patients who are going to take peginterferon alpha based regimen
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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 |
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nucleos(t)ide cohort
Patients who are going to take nucleos(t)ide alone
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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 |
Primary Outcome Measures :
- 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
- 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
- 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
- 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
- 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
- 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
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896255
Contacts
| Contact: Wenhong Zhang, Professor | 13801844344 | zhangwenhong@fudan.edu.cn | |
| Contact: Feng Sun, doctor | 15921403893 | aaronsf1125@126.com |
Locations
| China | |
| Huashan Hospital | Recruiting |
| Shanghai, China, 200040 | |
| Contact: Wenhong Zhang, Professor 13801844344 zhangwenhong@fudan.edu.cn | |
| Contact: Feng Sun, doctor 15921403893 aaronsf1125@126.com | |
Sponsors and Collaborators
Huashan Hospital
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
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:
| Responsible Party: | Wen-hong Zhang, Professor, Huashan Hospital |
| ClinicalTrials.gov Identifier: | NCT04896255 |
| Other Study ID Numbers: |
KY2020-911 |
| First Posted: | May 21, 2021 Key Record Dates |
| Last Update Posted: | May 21, 2021 |
| Last Verified: | May 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic |