CompletedPhase 2

A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection

China101 participantsStarted 2023-06-16

Plain-language summary

This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.

Who can participate

Age range18 Years – 70 Years

SexALL

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Exclusion criteria

✕. Total bilirubin \>2×ULN (except for subjects with Gilbert syndrome);
✕. Direct bilirubin \> 1.5×ULN ;
✕. Platelets\<80,000/mm3 (80×109/L);
✕. Serum Albumin \<35 g/L;
✕. Prothrombin time international normalized ratio (INR) \>1.3;
✕. Hemoglobin \<100 g/L;
✕. Absolute neutrophils\<1,500/mm3 (1.5×109/L);
✕. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 (according to the calculation equation of CKD-MDRD);

What they're measuring

Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization

Timeframe: At Week 24 of the treatment period

Trial details

NCT IDNCT05861674

SponsorHuahui Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-18

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