Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

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Review clinical trials related to Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 88 weeks at maximum for each participant.

Participants needed: 540
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Updated: May 26, 2026Locations: 1
Eligibility criteria

Chronic hepatitis B defined as HBV infection documented for at least 6 months pr... [+5]

History of cirrhosis or clinical evidence of hepatic decompensation, confirmed o... [+12]