A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treated Subjects With Chronic HBV Infection With Low-level Viremia (LLV)
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is a phase II multicenter, randomized, double-blind, placebo controlled study designed to evaluate the efficacy and safety in LLV subjects and demonstrate that TQA3605 tablets combined with oral NAs drugs can improve the efficacy and safety of LLV subjects compared with oral NAs drug.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Ages 18-65 (including boundary values), male or female.
• At the time of screening, etiological or clinical or pathological evidence of hepatitis B virus infection has been more than 1 year; HBsAg positive, 10 IU/mL \<HBV DNA≤2000 IU/mL, ALT≤3×ULN (upper limit of normal); No obvious cirrhosis was found by the researchers.
• Continuous administration of any nucleoside (acid) analogues for more than 1 year and a stable regimen of ≥6 months prior to screening.
• Able to communicate well with researchers, understand and comply with the requirements of the study, understand and sign the informed consent.
• Male subjects with fertile female partners or female subjects of childbearing age were willing to voluntarily take effective contraceptive measures within 3 months after screening.
Locations
Other Locations
China
Beijing Ditan Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology
NOT_YET_RECRUITING
Beijing
The Second XIANGYA Hospital Of Central South University
NOT_YET_RECRUITING
Changsha
Meng Chao Hepatobiliary Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
The First Affiliated Hospital Zhejiang University School Of Medicine
NOT_YET_RECRUITING
Hangzhou
Shandong Public Health Clinical Center
NOT_YET_RECRUITING
Jinan
Lishui People's Hospital
NOT_YET_RECRUITING
Lishui
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING
Nanjing
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Pudong Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Pudong New District Gongli Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Tongren Hospital
NOT_YET_RECRUITING
Shanghai
The sixth people's Hospital Of Shenyang
NOT_YET_RECRUITING
Shenyang
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
The Fifth People's Hospital of Suzhou
NOT_YET_RECRUITING
Suzhou
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING
Xi’an
Yueyang Central Hospital
NOT_YET_RECRUITING
Yueyang
Zhengzhou No.6 peoples Hospital
NOT_YET_RECRUITING
Zhengzhou
Zunyi Medical University Affiliated Hospital
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Qing Xie, Doctor
xq10403@rjh.com.cn
13651804273
Time Frame
Start Date:2024-11-14
Estimated Completion Date:2026-08
Participants
Target number of participants:120
Treatments
Placebo_comparator: TQA3605 Placebo plus NAs
TQA3605 placebo plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Experimental: 100mg TQA3605 tablets plus NAs
100mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
Experimental: 200mg TQA3605 tablets plus NAs
200mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks