Clinical trial NCT06990776: A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old (including boundary values), regardless of gender;
* Screening requires virological , clinical or pathological evidence of hepatitis B virus infection for more than 6 months; HBsAg positive, HBeAg positive, ALT≤5×ULN at screening;
* Never received nucleoside (acid) analog or interferon treatment, or previously received no more than 12 weeks of treatment but had discontinued therapy at least 6 months prior to the screening visit;
* Ability to communicate effectively with researchers and understand and comply with the requirements of this study, understand and sign the informed consent form;
* Male subjects with female partners who have fertility or female subjects of childbearing age are willing to voluntarily adopt effective contraceptive measures screening to within 3 months after leaving the group.

Exclusion Criteria:

* Pregnant (positive pregnancy test) or lactating women.
* Co-infection with other viruses such as Hepatitis A Virus (HAV), Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), Hepatitis E Virus (HEV), Human Immunodeficiency Virus (HIV), Syphilis, etc.;
* History of cirrhosis or evidence of significant fibrosis or cirrhosis before or during screening;
* History of hepatocellular carcinoma (HCC) or suspected HCC before or during screening.;
* History of malignant tumors within the past 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection;
* Subjects with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, Wilson's disease, Gilbert syndrome, etc;
* Previous organ or bone marrow transplantation;
* Clinically significant abnormal laboratory test results at screening.
* Poorly controlled thyroid diseases or clinically significant thyroid dysfunction;
* Autoimmune diseases;
* Significant systemic or major illnesses other than liver disease.
* Any systemic anti-tumor or immunosuppressive therapy, or immunomodulatory therapy within 6 months prior to screening.
* High-dose systemic corticosteroids use within 3 months prior to screening;
* History of alcohol or drug abuse within the past year or excessive alcohol consumption.
* History of blood transfusion within 2 months prior to screening;
* History of allergy to investigational drug or its excipients.
* Previously participated in the clinical trial of hepatitis B core protein allosteric modulators;
* Participation in another clinical trial and receipt of an investigational drug within the following timeframes before the first dose in this study: 5 half-lives (if known) or twice the duration of the biological effect of the study treatment (if known), whichever is longer, or 90 days (if the half-life or duration is unknown);
* History or condition of cardiovascular disease;
* Any other condition deemed inappropriate for inclusion by the investigator.

Primary outcomes:
measure: hepatitis B virus (HBV) DNA <10 IU/mL
timeFrame: 48 weeks
Secondary outcomes:
measure: Percentage of subjects with HBV DNA<10 IU/mL
timeFrame: 12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks
measure: Percentage of HBV DNA<20 IU/mL
timeFrame: 12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks
measure: Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
timeFrame: 24weeks, 48 weeks, 72 weeks
measure: Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN)
timeFrame: 24weeks, 48 weeks, 72 weeks
measure: Virology breakthrough percentage
timeFrame: 24weeks, 48 weeks, 72 weeks
measure: Actual values of HBV markers and changes over time relative to baseline
timeFrame: 12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks
measure: Adverse events (AE)
timeFrame: 72 weeks
measure: Steady state minimum concentration (Cmin,ss)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: ChongQing
country: China
facility: The Southwest Hospital of AMU
state: Chongqing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: NanFang Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of GUANGXI Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Zhengzhou No.6 peoples Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: Naniing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Fifth People's Hospital of Suzhou
state: Jiangsu
city: Wuxi
country: China
facility: The Fifth People's Hospital of Wuxi
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang Third People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Jiaotong University Second Affiliated Hospital
state: Shaanxi
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Clinical Center for Public Health
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Yiwu
country: China
facility: Yiwu Central Hospital
state: Zhejiang
Study officials:
References: