ITMCTR2200006805招募中4 期
A randomized, double-blind, loading, placebo-controlled, multicenter clinical study on the efficacy and safety of Polyporus polysaccharide capsule combined with entecavir in the treatment of low-level 
Beijing You'an Hospital Affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •Inclusion criteria
- •The following criteria must be met before entering the study:
- •(1) It complies with the guidelines for the prevention and treatment of chronic hepatitis B (2019 Edition) prepared and revised by the infectious diseases branch of the Chinese Medical Association and the hepatology branch of the Chinese Medical Association, and is clinically diagnosed as a patient with chronic hepatitis B;
- •(2) TCM syndrome differentiation is liver and gallbladder damp heat syndrome;
- •(3) The age is 18 ~ 70 years old (including upper and lower limits), and the sex is unlimited;
- •(4) The subjects of childbearing age are willing to start from the date of signing the informed consent form to 3 months after the last administration
- •Willing to take adequate contraceptive measures and agree to use non drug complete contraception during the study period;
- •(5) Antiviral therapy with entecavir for at least 6 months;
- •(6) Agree not to change the current antiviral treatment plan during this study;
- •(7) 500 IU/mL
- •(8) Outpatient;
- •(9) Sign informed consent and voluntarily participate in the clinical trial.
排除标准
- •Exclusion criteria
- •All the following criteria must be met before entering the study:
- •(1) Hepatocellular tumors with the following evidences: n suspicious lesions were found by B-ultrasound or imaging examination;
- •The serum alpha fetoprotein (AFP) in the past was continuously increased with normal B-ultrasound;
- •B-ultrasound was not checked, but AFP > 100 ng/ml.
- •(2) There were clinical manifestations of decompensated liver disease at baseline, and the following indicators could suggest that N had a history of ascites, esophageal variceal bleeding or hepatic encephalopathy;
- •Other clinical manifestations suggest decompensated liver disease.
- •(3) ALT or ast value exceeds 2 times the upper limit of normal value, or serum bilirubin exceeds the upper limit of normal value.
- •(4) There is the possibility of liver function decompensation due to the aggravation of liver disease.
- •(5) Chronic nephropathy or creatinine clearance rate < 60 ml/min were found during screening.
- •(6) Hemoglobin: male < 100 g/l, female < 90 g/l; WBC count < 3.0 × 109/L Platelet < 80 × 109/L
- •(7) Co infection with HCV, HDV, HIV, with autoimmune hepatitis or active hepatitis caused by other reasons.
- •(8) For any serious systemic disease other than hepatitis B, the researcher believes that it may interfere with the treatment or compliance of the subjects, including any uncontrolled urinary, circulatory, respiratory, nervous, mental, digestive, endocrine, immune and other system diseases and tumors of clinical significance.
- •(9) The subject has a history of alcoholism or drug abuse, and the researcher believes that he cannot comply with the protocol or affect the result analyst.
- •(10) Specific transaminase lowering drugs (such as bifendate or other Schisandra preparations) have been used within 1 month.
- •(11) Two months before screening or it is estimated that the subjects may use nephrotoxic drugs (such as aminoglycosides, amphotericin B, vancomycin, pentamidine, cisplatin, etc.) or drugs that are excreted competitively through the kidney (such as probenecid, etc.) during the study.
- •(12) Patients treated with more than 2 kinds of antiviral drugs.
- •(13) The researcher judged that the subjects' compliance was poor.
- •(14) Allergic constitution (such as those who are allergic to two or more drugs and food) or have a history of allergy to ingredients such as Polyporus umbellatus.
- •(15) Pregnant or lactating women or those with birth planning.
- •(16) Those who have participated in clinical trials of other drugs in recent 3 months.
- •(17) The researcher thinks that it is not suitable to participate in the clinical trial.
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