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NCT05839639Not yet recruiting

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors

A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors
Huahui HealthPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
NrtIs
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Huahui Health
Location
Guangzhou, China
Timeline & enrollment
Phase
Phase 2
Start date
Oct 09, 2021
End date
May 30, 2023
Enrollment
73 participants
Primary outcome

Proportion of participants achieving sustained viral response,Changes from baseline in serum HBsAg levels

Summary

This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003
 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate
 the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B
 treated with nucleos(t)ide reverse transcriptase inhibitors.

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05839639
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05839639 through Pure Global AI's free database. This Phase 2 trial is sponsored by Huahui Health and is currently Not yet recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 73 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.