Menu
Recruiting NCT07179575

Study of LW231 in Participants With Chronic Hepatitis B

Phase I / Phase II Interventional Chronic HBV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LW231, LW231 placebo.
Who it may be relevant to
Registry conditions: Chronic HBV Infection. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Drug LW231
    LW231 tablets
  • Drug LW231 placebo
    LW231 placebo tablets

Primary outcome measures

  • Change from baseline in HBV DNA Viral Load Assay [Time frame: 4 weeks]
Secondary outcome measures (4)
  • Number of Participants With Adverse Events (AEs) [Time frame: up to 28 weeks]
  • Change from baseline in HBsAg [Time frame: Up to 28 weeks]
  • Maximum Plasma Concentration (Cmax) of LW231 [Time frame: Up to 28 Weeks]
  • Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231 [Time frame: Up to 28 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07179575 · LW231-Ib/II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗