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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 - Trial NCT05839639

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.

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NCT05839639
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05839639
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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

Study Focus

Chronic Hepatitis B

NrtIs

Interventional

drug

Sponsor & Location

Huahui Health

Guangzhou, China

Timeline & Enrollment

Phase 2

Oct 09, 2021

May 30, 2023

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 B
Chronic viral hepatitis B without delta-agent
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent : other and unspecified phase
Chronic viral hepatitis B without delta-agent : immune-tolerant phase

Data Source

ClinicalTrials.gov

NCT05839639

Non-Device Trial