TQA3038 injection/placeboNucleotide drugs Control group
TQA3038 injection/placebo: TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Nucleotide drugs Control group: Nucleotide drugs are nucleoside reverse transcriptase inhibitors.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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;
* Patients with significant liver fibrosis or cirrhosis before or during screening;
* History of chronic liver diseases other than chronic HBV infection;
* Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
* Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;
* During screening, subjects showed significant laboratory results abnormalities;
* Screening for tumors with a history of malignancy within the first 5 years, excluding tumors that can be completely cured through surgical resection;
* Uncontrollable chronic diseases;
* History of intolerance to subcutaneous injection;
* Participated in clinical studies of any drug or medical device within 3 months prior to drug administration or within 5 times the half-life of the investigational drug, or used the investigational drug;
* Those considered unsuitable for enrollment by the investigators.
Primary outcome measure(s)
Adverse events (AEs) — Baseline up to 16 weeks The incidence of adverse events (AEs) during treatment.
Serious adverse events (SAEs) — Baseline up to 16 weeks The incidence of serious adverse events (SAEs) during treatment.
Hepatitis B virus surface antigen (HbsAg) — Baseline up to 48 weeks Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
Trial sites (22)
Facility
City
Region
Status
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Anhui
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou
Fujian
Gansu province people hospital
Lanzhou
Gansu
The Third Affiliated Hospital of Sun Yat sen University
Guangzhou
Guangdong
The First Affiliated Hospital of GUANGXI Medical University
Nanning
Guangxi
Guizhou Provincial People's Hospital
Guiyang
Guizhou
The Fourth Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Shiyan City Taihe Hospital
Shiyan
Hubei
Tongji Hospital of Tongji medical college of HUST
Wuhan
Hubei
Xiangya Third Hospital of Central of Central Suoth University
Changsha
Hunan
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
The first hospital of Jilin University
Changchun
Jilin
Hepatobiliary Hospital of Jilin
Changchun
Jilin
The sixth people's hospital at of Shenyang
Shenyang
Liaoning
Shengjing Hospital Affiliated to China Medical University
Shenyang
Liaoning
Shandong Public Health Clinical Center
Jinan
Shandong
West China Hospital of Sichuan University
Chengdu
Sichuan
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
The Southwest Hospital of AMU
Chongqing
China
The Second Affilated Hospital of Chongqing medical university
Chongqing
China
Shanghai Tongren Hospital
Shanghai
China
People's Hospital of Tianjin (City)
Tianjin
China
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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