A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
NCT ID: NCT06452693
Last Updated: 2024-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
162 participants
INTERVENTIONAL
2024-06-30
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TQA3038 injection/placebo
100/0mg\~400/0mg, subcutaneous injection, 2 weeks\~8 weeks as a cycle, a total of 2 doses.
Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks.
TQA3038 injection/placebo
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Nucleotide drugs Control group
Nucleotide drugs: Oral, once a day, orally administered with food, for 48weeks.
Nucleotide drugs Control group
Nucleotide drugs are nucleoside reverse transcriptase inhibitors.
Interventions
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TQA3038 injection/placebo
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Nucleotide drugs Control group
Nucleotide drugs are nucleoside reverse transcriptase inhibitors.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first hospital of Jilin University
Changchun, Jilin, China
Hepatobiliary Hospital of Jilin
Changchun, Jilin, China
The sixth people's hospital at of Shenyang
Shenyang, Liaoning, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQA3038-Ib/IIa-01
Identifier Type: -
Identifier Source: org_study_id
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