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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How do rates of HBsAg seroclearance, decompensated cirrhosis, liver fibrosis progression, and other virological and clinical outcomes compare across regimens? Researchers will compare real-world treatment arms-including nucleos(t)ide analogue (NA) monotherapy (e.g., entecavir, tenofovir), PegIFN based regimen (e.g., PegIFN monotherapy, PegIFN plus NA combinations)-to identify optimal strategies for reducing HCC risk and improving functional cure rates. Participants will undergo routine clinical care with no study-imposed interventions; data on demographics, medical history, symptoms, laboratory tests (e.g., HBsAg, HBV DNA, liver function), imaging (e.g., ultrasound, elastography), and clinical events will be collected prospectively (for up to 5 years in some cohorts) or retrospectively from medical records at baseline and scheduled follow-up visits (e.g., every 3-12 months initially, then annually).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 or currently receiving potent low-resistance NAs \[entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)\], or planned to receive PegIFNα-2b, either treated or treatment-naïve.

• Agree to participate in the study and sign the patient informed consent form.

Locations
Other Locations
China
Huashan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Wenhong Zhang, Professor
zhangwenhong@fudan.edu.cn
13801844344
Backup
Feng Sun, doctor
aaronsf1125@126.com
15921403893
Time Frame
Start Date: 2020-09-09
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 33000
Treatments
Prospective
CHB patients enrolled pre-Protocol v3.0 (Dec 2023), planned or on antiviral therapy, followed prospectively for 5 years post-consent. Treatments: routine NA monotherapy, or PegIFN based regimens, per clinical guidelines. Data: baseline and 5 -year follow-up via routine visits.
Retrospective-Prospective
CHB patients with baseline (≥Sep 2020) pre-v3.0, consenting post-v3.0. Retrospective data from baseline to consent; prospective for 5 years from baseline. Treatments: NAs monotherapy, or PegIFN based regimens. Data: retrospective before consent; prospective from visit matching baseline-consent interval. Missing routine data noted.
Retrospective
CHB patients with records from Sep 2020 to v3.0 (Dec 2023), collected retrospectively. Treatments: NAs monotherapy, or PegIFN based regimens, per historical practice. Data: extracted from the electronic healthcare record; missing routine data recorded.
Sponsors
Collaborators: The First Affiliated Hospital of Xiamen University, Qingdao No.6 People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Tianjing No.2 People's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yunnan Provincial No.1 Hospital, Beijing YouAn Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Taicang No.1 People's hospital, Chinese Foundation for Hepatitis Prevention and Control, The Third People's Hospital of Taiyuan, First Affiliated Hospital of Chongqing Medical University, Henan Provincial People's Hospital, Beijing Ditan Hospital, Ningbo Beilun District Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Anhui Medical University, Wuxi No.5 People's Hospital
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov

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