Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
- Conditions
- Chronic Hepatitis b
- Interventions
- Drug: peginterferon alpha based regimenDrug: nucleos(t)ide
- Registration Number
- NCT04896255
- Lead Sponsor
- Huashan Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- 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.
- Currently treatment-related participating clinical trials.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description interferon cohort peginterferon alpha based regimen Patients who are going to take peginterferon alpha based regimen nucleos(t)ide cohort nucleos(t)ide Patients who are going to take nucleos(t)ide alone
- Primary Outcome Measures
Name Time Method rate of hepatocellular carcinoma at 1 year from baseline 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 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 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 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 5 years from baseline Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease
- Secondary Outcome Measures
Name Time Method rate of HBsAg loss 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 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.
HBsAg level 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.
rate of HBeAg conversion 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 regression 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.
rate of fibrosis progression 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.
Trial Locations
- Locations (1)
Huashan Hospital
🇨🇳Shanghai, China