ETV、TQ-A3334 和 TQ-B2450 的组合用于 CHB(海王星研究) (Neptune)
ETV、TQ-A3334和TQ-B2450治疗慢性乙型肝炎病毒感染的新组合
This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Hubei
-
Wuhan、Hubei、中国、430030
- Tongji Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male and female patients from 18 to 65 years of age;
- Chronic hepatitis B infection
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
- Agree to participate in the study and sign the patient informed consent.
Exclusion Criteria:
- Patients who had NAs resistance;
- Other antiviral, anti-neoplastic or immunomodulatory treatment;
- Women with ongoing pregnancy or breast-feeding;
- Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
- ALT >10 ULN;
- LSM >9kPa ;
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
- Signs or symptoms of hepatocellular carcinoma;
- Neutrophil count < 1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening;
- Hemoglobin < 11.5 g/dL for females and <12.5 g/dL for men;
- Serum creatinine level > 1.5 ULN in screening period.
- Phosphorus < 0.65 mmol/L;
- ANA > 1:100;
- History of severe psychiatric disease;
- History of a severe seizure disorder or current anticonvulsant use;
- History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
- History of chronic pulmonary disease associated with functional limitation;
- Diseases that IFN and Nucleotides or nucleosides are not suitable.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Naive:ETV
Entecavir 0.5 mg po daily for 24 weeks in naive patients |
entecavir 0.5 mg qd |
|
实验性的:Naive:ETV+TQ-A3334
Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients |
entecavir 0.5 mg qd TQ-A3334 po qw |
|
实验性的:Naive:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients |
entecavir 0.5 mg qd TQ-A3334 po qw TQ-B2450 q3w iv |
|
有源比较器:Experienced:ETV
Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients |
entecavir 0.5 mg qd |
|
实验性的:Experienced:ETV+TQ-A3334
Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients |
entecavir 0.5 mg qd TQ-A3334 po qw |
|
实验性的:Experienced:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients |
entecavir 0.5 mg qd TQ-A3334 po qw TQ-B2450 q3w iv |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in HBsAg quantification at week 24
大体时间:week 24
|
HBsAg quantification are measured |
week 24
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HBsAg loss rates at week 24
大体时间:week 24
|
HBsAg loss rates are measured |
week 24
|
|
HBsAg seroconversion rates at week 24
大体时间:week 24
|
HBsAg seroconversion rates are measured |
week 24
|
|
HBeAg loss rates at week 24
大体时间:week 24
|
HBeAg loss rates are measured |
week 24
|
|
HBeAg seroconversion rates at week 24
大体时间:week 24
|
HBeAg seroconversion rates are measured |
week 24
|
|
HBV DNA<20IU/mL rates at week 24
大体时间:week 24
|
HBV DNA<20IU/mL rates are measured |
week 24
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.