Clinical trial NCT04896255: Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
Official title: Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Prospective, Multicenter, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis b
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Foundation for Hepatitis Prevention and Control
name: The Third People's Hospital of Taiyuan
name: First Affiliated Hospital of Chongqing Medical University
name: Beijing YouAn Hospital
name: Henan Provincial People's Hospital
name: Yunnan Provincial No.1 Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Anhui Medical University
name: The First Affiliated Hospital of Xiamen University
name: Beijing Ditan Hospital
name: Tianjing No.2 People's Hospital
name: Qingdao No.6 People's Hospital
name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Ningbo Beilun District Traditional Chinese Medicine Hospital
name: Wuxi No.5 People's Hospital
name: Taicang No.1 People's hospital
name: First Affiliated Hospital Xi'an Jiaotong University
First posted: 2021-05-21
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: rate of hepatocellular carcinoma at 1 year from baseline
timeFrame: 1 year from baseline
measure: rate of hepatocellular carcinoma at 3 years from baseline
timeFrame: 3 years from baseline
measure: rate of hepatocellular carcinoma at 3 years from baseline
timeFrame: 5 years from baseline
measure: rate of decompensated cirrhosis at 1 year from baseline
timeFrame: 1 year from baseline
measure: rate of decompensated cirrhosis at 3 years from baseline
timeFrame: 3 years from baseline
measure: rate of decompensated cirrhosis at 5 years from baseline
timeFrame: 5 years from baseline
Secondary outcomes:
measure: rate of HBsAg loss
timeFrame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
measure: rate of HBeAg loss
timeFrame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
measure: rate of HBeAg conversion
timeFrame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
measure: rate of fibrosis progression
timeFrame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
measure: rate of fibrosis regression
timeFrame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
measure: HBsAg level
timeFrame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Wenhong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Jiming Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Feng Sun, MD
role: STUDY_CHAIR
affiliation: Huashan Hospital
name: Qiran Zhang, MD
role: STUDY_DIRECTOR
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