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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&#32

Registration number：

ITMCTR2200006805

Date of Last Refreshed on：

2022-11-21

Date of Registration：

2022-11-21

Registration Status：

Prospective registration

Public title：

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&#32

English Acronym：

Scientific title：

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&#32

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065999 ; ChiMCTR2200006805

Applicant：

TaoSun

Study leader：

XiuHuiLi

Applicant telephone：

13717779613

Study leader's telephone：

13501273210

Applicant Fax：

Study leader's fax：

Applicant E-mail：

suntao@kangzhongshidai.com

Study leader's E-mail：

lixiuhui@sohu.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

6 / F, Rongda international, No. 201, South West Third Ring Road, Fengtai District, Beijing

Study leader's address：

8 xitoutiao, youanmenwai, Fengtai District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

eijing Kangzhongshidai Medical Research Development Co., Ltd

Approved by ethic committee：

Approved No. of ethic committee：

京佑科伦字【2022】083号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Beijing You'an Hospital Affiliated to Capital Medical University

Date of approved by ethic committee：

2022/6/15 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Beijing You'an Hospital Affiliated to Capital Medical University

Primary sponsor's address：

8 xitoutiao, youanmenwai, Fengtai District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

湖北梦阳药业股份有限公司 Hubei Mengyang Pharmaceutical Co., Ltd

Address：

Fuyao 1st Road, Jingmen Economic Development Zone, Hubei Province

Source(s) of funding：

Mengyang Pharmaceutical Co., Ltd

Target disease：

Low level viremia of chronic hepatitis B

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

A randomized, double-blind, loading, placebo-controlled, multicenter clinical study design was used to preliminarily explore the efficacy and safety of Polyporus polysaccharide capsule combined with entecavir in the treatment of chronic hepatitis B low-level viremia, so as to provide data support and basis for the follow-up clinical study design.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

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 <HBV DNA < 2000 IU/mL (8) Outpatient; (9) Sign informed consent and voluntarily participate in the clinical trial.

Exclusion criteria：

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.

Study execute time：

From 2022-11-21

To      2025-12-31

Recruiting time：

From 2022-11-21

To      2025-12-31

Interventions：

30

Group：

Control group

Sample size：

Intervention：

Routine treatment + Polyporus polysaccharide capsule simulation agent

Intervention code：

30

Group：

Test group

Sample size：

Intervention：

Routine treatment + Polyporus polysaccharide capsule

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Zhejiang

City：

Institution/hospital：

浙江医院

Level of the institution：

Class III class A

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Ditan Hospital, Capital Medical University

Level of the institution：

Class III class A

Country：

China

Province：

Beijing

City：

Fengtai District

Institution/hospital：

Beijing You'an Hospital Affiliated to Capital Medical University

Level of the institution：

Class III class A

Country：

China

Province：

Heibei

City：

Institution/hospital：

Shijiazhuang Fifth Hospital

Level of the institution：

Class III

Outcomes：

Outcome：

Change of TCM syndrome score of subjects

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The magnitude of the subject's serum HBV DNA decline

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of HBeAg-negative and HBEAB-positive seroconversion in subjects (%)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of negative serum HBVDNA in subjects (%)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of HBsAg negative serum in subjects (%)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The quantitative reduction of serum HBsAg in subjects

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Block randomization method was used. With the help of SAS statistical software, 60 subjects were selected for treatment (experimental group and control group) were randomly arranged.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Sponsor

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic data capture (EDC)

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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