Status:
RECRUITING
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Chinese Foundation for Hepatitis Prevention and Control
The Third People's Hospital of Taiyuan
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18+ years
Brief 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 ai...
Detailed Description
The OASIS study is a multicenter, observational, real-world cohort study designed to evaluate long-term outcomes of antiviral therapies for chronic hepatitis B (CHB). It compares nucleos(t)ide analogu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline
- Concurrently participating in other interventional clinical trials.
- Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
33000 Patients enrolled
Trial Details
Trial ID
NCT04896255
Start Date
September 9 2020
End Date
December 31 2031
Last Update
October 6 2025
Active Locations (1)
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1
Huashan Hospital
Shanghai, China, 200040