NCT06452693

A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	TQA3038 injection/placebo	TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
DRUG	Nucleotide drugs Control group	Nucleotide drugs are nucleoside reverse transcriptase inhibitors.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

22 sites across 1 country: China