Not Yet RecruitingPhase 3

A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB

China1,300 participantsStarted 2025-08

Plain-language summary

This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Hemoglobin \< 110 g/L (for males) or \< 100 g/L (for females);
✕. Platelet count \< 90 × 109/L;
✕. Neutrophil count \< 1.5 × 109/L;
✕. Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)\> 3 × upper limit of normal (×ULN);
✕. International normalized ratio (INR) of prothrombin time \> 1.3;
✕. Albumin \< 35 g/L;
✕. Total bilirubin \> 2 × ULN, and direct bilirubin \> 1.5 × ULN;
✕. Estimated glomerular filtration rate \< 60 mL/min/1.73 m2(calculated using the CKD-MDRD formula).

What they're measuring

Percentage of subjects achieves complete virologic response (CVR) at week 48 of treatment.

Timeframe: 48 week

Trial details

NCT IDNCT07095855

SponsorShanghai Zhimeng Biopharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Project Manager

+8615800984667 adeng@corebiopharma.com

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