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

Recruiting Phase 3 Interventional Study
Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
540 (estimated)
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
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About This Trial
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),NAs-only treatment stage(12 weeks) and th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening; 2. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation; 3. HBeAg negative at screening; 4. On commercially…
Contacts

Xiaopeng Wang

0518-82342973

xiaopeng.wang@hengrui.com

CONTACT