About this trial
The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B.
Participants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months;
Age between 18-80 years, gender is not limited；
Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy;
Patient who reads and signs informed consent.
Disqualifiers
Patients with malignancies other than hepatocellular carcinoma.
Trial population
Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon \[IFN\] monotherapy, a potent nucleos(t)ide analogue \[NA\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
nucleoside analogues or interferon
DrugETV、TDF、TAF、TAF、IFN-a-2b
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period
Number of Participants with Diagnosis of hepatocellular carcinoma
Secondary outcomes
Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period
Number of Participants with Diagnosis of participants with decompensation cirrhosis
Number of Participants with Diagnosis of participants with liver transplantation during the observation period
Number of Participants with Diagnosis of participants with liver transplantation
Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period
Number of Participants with Diagnosis of participants with fibrosis regression and progression
Number of Participants with Diagnosis of participants with serological response during the observation period
Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg
Sponsors and contacts
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Wen-hong Zhang
Lead sponsor
Huashan Hospital
Sponsor institution
Shandong Provincial Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
The Third People's Hospital of Taiyuan
Collaborator
The First People's Hospital of Yunnan
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: