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

NOT_YET_RECRUITINGPHASE1/PHASE2

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

NCT06452693•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects voluntarily participate in this study and sign informed consent;
•Male and female ≥18 years old and ≤65 years old;
•Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18\~28 kg/m2;
•Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
•The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
•The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;
•The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;
•Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.

Exclusion Criteria

•Pregnant and lactating women;
•Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
•Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
•Individuals with a history of active pathological bleeding or a tendency towards bleeding;
•Prescription medication has been used within 14 days prior to receiving the study drug;
•Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;
•Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;
•Subjects with a history of excessive alcohol consumption;
•A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;
•Complicated with other infected disease;
+10 more criteria

Locations (22)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Gansu province people hospital

Lanzhou, Gansu, China

The Third Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of GUANGXI Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Shiyan City Taihe Hospital

Shiyan, Hubei, China

Tongji Hospital of Tongji medical college of HUST

Wuhan, Hubei, China

Xiangya Third Hospital of Central of Central Suoth University

Changsha, Hunan, China

Key Dates

Start Date

June 1, 2024

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

June 11, 2024

Enrollment

162

ESTIMATED participants

Conditions

Hepatitis B, Chronic

Interventions

TQA3038 injection/placebo

DRUG

Nucleotide drugs Control group

DRUG

Contacts

Qin Ning, Doctor

CONTACT

13971521450 qning@vip.sina.com

Junqi Niu, Doctor

CONTACT

13756661205 junqiniu@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels