LW231 treatment for people with chronic hepatitis B
Phase Ib/II Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)
This trial tests whether LW231, given alone or with standard antiviral NUCs, is safe and can lower hepatitis B virus measures in adults with chronic HBV.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Shanghai Longwood Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Trial ID | NCT07179575 on ClinicalTrials.gov |
What this trial studies
This Phase Ib/II, multicenter, randomized dose-escalation trial will give multiple doses of LW231 and compare active drug to placebo, including arms that combine LW231 with nucleos(t)ide analogs (NUCs). The study will collect safety, tolerability, pharmacokinetic, and pharmacodynamic data as well as preliminary efficacy signals such as reductions in HBV DNA and HBsAg. Participants include both treatment-naïve patients with low-to-moderate viremia and patients already suppressed on NUCs but with measurable HBsAg. Regular clinic visits and laboratory monitoring will be used to track adverse events and antiviral responses over the dosing and follow-up periods.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic HBV who meet the trial viral-load and HBsAg ranges (part 1: LLOQ < HBV DNA ≤ 20,000 IU/mL and HBsAg 100–10,000 IU/mL; part 2: HBV DNA < LLOQ or < 20 IU/mL and HBsAg 100–3,000 IU/mL) and who do not have cirrhosis or other exclusionary conditions.
Not a fit: People with co-infections (HAV, HCV, HDV, HEV, or HIV), cirrhosis, or significant liver test abnormalities are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, LW231 could offer a new treatment option that better suppresses HBV and lowers HBsAg, potentially improving chances for long-term viral control.
How similar studies have performed: Other early-phase trials combining novel antivirals with NUCs have shown promising antiviral activity, but a broadly effective cure for chronic HBV has not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Part 1: treatment-naïve and currently not treated subjects: LLOQ\<HBV DNA≤20000 IU/ml; 100 IU/mL\<HBsAg\<10000 IU/ml * Part 2: HBV DNA\<LLOQ or \< 20 IU/mL at screening; 100 IU/mL\<HBsAg\<3000 IU/mL Exclusion Criteria: * Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. * History or current evidence of cirrhosis. * ALT or AST\>3×ULN; TBil\>1.3×ULN or DBil\>1.3×ULN; INR\>1.3×ULN
Where this trial is running
Hangzhou, Zhejiang and 1 other locations
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.