NCT06644417已完成2 期
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)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 40
- 主要终点
- HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant (positive pregnancy test) or breastfeeding women.
- •Co-infection with other viruses such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, syphilis.
- •A history of cirrhosis or evidence of significant fibrosis or cirrhosis at pre-screening/screening time.
- •The subject had a history of hepatocellular carcinoma (HCC) before or at the time of screening, or was suspected of HCC.
- •A history of malignant tumors within 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, and hepatolenticular degeneration.
- •Have previously received organ transplantation and bone marrow transplantation.
- •Abnormal laboratory examination indicators that do not meet the requirements of the program during screening.
- •Poorly controlled thyroid disease, or clinically significant thyroid dysfunction.
- •Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis, etc.;
- •In addition to liver disease, there are significant systemic or major diseases, including recent congestive heart failure, unstable coronary heart disease, arterial revasodilation, respiratory disease, digestive disease, renal insufficiency, stroke, transient ischemic attack, organ transplantation, psychiatric disease, etc. Uncontrolled systemic disease: poor blood pressure control; Diabetes has poor blood sugar control.
- •Received any systemic antitumor (including radiation) or immunosuppressive therapy (including biological immune inhibitors), or immunomodulatory therapy (including non-biological immunomodulatory oral drugs) in the 6 months prior to screening.
- •Receiving high doses of systemic corticosteroids within 3 months prior to the screening period.
- •A history of alcohol and drug abuse within 1 year prior to the screening period.
- •Blood transfusion ≤2 months before screening and/or blood donation ≤1 month before screening. Note: Participants were not allowed to donate blood throughout the study period.
- •Have a history of allergy to the experimental drug or its excipients.
- •Participated in clinical trials of hepatitis B core protein allosteric regulators.
- •The subject has participated in a clinical trial and received the investigational drug during the period prior to the first administration of the study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days (if the half-life or duration is unknown).
- •History or status of cardiovascular disease: history of risk factors for tip torsion ventricular tachycardia, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory tests. Family history of long QT syndrome or Brugada syndrome. The Electrocardiogram (ECG) showed clinically significant abnormalities. Heart Rate (HR)≤45 bpm.
- •Those that researchers believe should not be included.
研究组 & 干预措施
TQA3605 Placebo plus NAs
Placebo Comparator
TQA3605 placebo plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
干预措施: TQA3605 Placebo plus NAs (Drug)
100mg TQA3605 tablets plus NAs
Experimental
100mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
干预措施: TQA3605 tablets plus NAs (Drug)
200mg TQA3605 tablets plus NAs
Experimental
200mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks
干预措施: TQA3605 tablets plus NAs (Drug)
结局指标
主要结局
HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)
时间窗: 24 weeks
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (\<10 IU/mL) at 24 weeks of treatment
次要结局
- Incidence and severity of Adverse events (AEs)(32 weeks)
- Incidence and severity of serious adverse events (SAEs)(32 weeks)
- HBV DNA (<10 IU/mL)(Weeks 12, Weeks 16, Weeks 24, Weeks 28, Weeks 32)
- Hepatitis B e antigen (HBeAg) Serology(Weeks 12, Weeks 24, Weeks 32)
- Alanine Aminotransferase (ALT) relapse rate(Weeks 12, Weeks 24, Weeks 32)
- Breakthroughs in virology(Weeks 12, Weeks 24, Weeks 32)
- Actual values and changes of HbsAg (Hepatitis B Surface Antigen)(Weeks 12, Weeks 24, Weeks 32)
- Actual values and changes of HBeAg(Weeks 12, Weeks 24, Weeks 32)
- Actual values and changes of HBV DNA(Weeks 12, Weeks 24, Weeks 32)
- HBV RNA (Hepatitis B virus Ribonucleic Acid)(Weeks 12, Weeks 24, Weeks 32)
- Actual values and changes of Human Hepatitis B virus core antigen - associated antigen (HbcrAg)(Weeks 12, Weeks 24, Weeks 32)
- (Cmax, ss) Steady-state maximum concentration(Day 1, Day 29, Day 57, Day 85, Day 113, Day 169)
- (Cmin, ss) Steady state minimum concentration(Day 1, Day 29, Day 57, Day 85, Day 113, Day 169)
- HBV DNA (<10 IU/mL)(Weeks 12, Weeks 16, Weeks 28, Weeks 32)
研究者
研究点 (40)
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