Actively Recruiting
Study of LW231 in Participants With Chronic Hepatitis B
Led by Shanghai Longwood Biopharmaceuticals Co., Ltd. · Updated on 2025-10-02
270
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ib/II, multicenter, randomized, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of LW231 in participants with chronic hepatitis B virus (HBV) infection. The trial will include multiple-dose regimens of LW231 and assess LW231 in combination with NUCs.
CONDITIONS
Official Title
Study of LW231 in Participants With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Part 1: treatment-nafve and currently untreated participants with HBV DNA 2000 IU/ml and HBsAg between 100 and 10,000 IU/ml
- Part 2: participants with HBV DNA below lower limit of quantification or <20 IU/ml at screening, and HBsAg between 100 and 3,000 IU/ml
You will not qualify if you...
- Co-infection with hepatitis A, C, D, E, or HIV or any clinically significant liver disease not caused by HBV
- History or current evidence of cirrhosis
- Elevated liver enzymes: ALT or AST >3 times upper limit of normal
- Elevated bilirubin levels: total bilirubin >1.3 times upper limit of normal or direct bilirubin >1.3 times upper limit of normal
- INR above 1.3 times upper limit of normal
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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