The Clinical Trial of the Anti Hepatitis B Placenta Transfer Factor Injection

NCT ID: NCT02412319

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

Brief Summary

Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.

Detailed Description

This study using entecavir tablets as basic therapy, is a randomized, double-blind, placebo-controlled multi center study, including the screening period (-4 weeks), baseline and treatment period (96 weeks). The treatment period of first 48 weeks, using entecavir tablets as basic treatment, placebo-controlled trials; the second 48 weeks, taking entecavir tablets alone, continue observation experiment.

Conditions

HBeAg Positive Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group

Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Group Type: EXPERIMENTAL

Anti-HBV placenta transfer factor injection

Intervention Type: DRUG

Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Comparator Group

Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Interventions

Anti-HBV placenta transfer factor injection

Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Intervention Type: DRUG

Placebo

Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. aged 18-65, sex not limited;

2. patients with HBeAg positive chronic hepatitis B: Screening HBsAg positive for more than 6 months; screening HBeAg positive; screening serum HBV DNA≥1.0×105U/ml；

3. 2 * ULN (2 times the upper limit of normal value) < ALT <10 * ULN (10 times the upper limit of normal value);;

4. total bilirubin <51μmol/L;

5. hepatitis B virus resistance gene sequencing negative;

6. agree in the process of the study, do not participate in any other clinical studies or other anti HBV therapy;

7. before the beginning of the study, understand and sign the informed consent form approved by the ethics committee, and cooperate to conduct clinical research according to the requirements for the study.

Exclusion Criteria

1. by the following evidences prompt suspected hepatocellular carcinoma: B ultrasound or imaging examination discover occupying lesion;B ultrasound normal but serum alpha fetoprotein (AFP) level has a continuous increasing trend; AFP > 100ng/ml, and after review, still so.

2. with liver disease acute exacerbation cause a transient liver function decompensation disease or baseline with clinical performance of decompensated liver disease;

3. serum creatinine ≥1.5mg/dl (≥130μmol/l);

4. the serum amylase > 2 times the normal reference upper limit value;

5. hemoglobin (male <100g/L, female <90g/L), white blood cell< 3.5* 109/L, platelet< 60 * 109/L;

6. combined with infection of HCV (anti -HCV positive), HIV, anti -HAV IgM positive, anti -HDV IgM positive, anti -HEV IgM positive, anti -EBV IgM positive, anti -CMV IgM positive, autoimmune hepatitis(such as the titer of anti nuclear antibody> 1:160) or activite liver disease caused by other known or unknown reason;

7. investigators consider that may interfere with the treatment,evaluation or compliance of the subjects, including any uncontrolled clinical significance of kidneys, heart, lungs, blood vessels, neurogenic, digestive system, metabolic diseases (diabetes, hyperthyroidism, adrenal disease), immune function disorder or tumor;

8. subjects with a history of alcoholism or drug abuse,investigators consider the subjects cannot comply with this protocol or affect the results analysis;

9. pregnancy,lactation or female subjects plan to conceive or the companions of male subjects plan to conceive during the study

10. 6 months before the study medication used immunosuppressants,immunomodulators(thymosin alpha), cytotoxic drugs;

11. 6 months before the study medication used anti HBV drug therapy (interferon, Lamivudine, Adefovir, Entecavir and Telbivudine, Tenofovir,etc);

12. plan or have had liver transplantation;

13. received other study drug treatment within 3 months prior to screening;

14. drug allergy history or allergic for Nucleoside or Nucleotide drug;

15. the subjects non compliance with the protocol or subjects exist any situation which investigators considered not suitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shineway Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guiqiang Wang, Doctor

Role: STUDY_CHAIR

Peking University First Hospital

Maorong Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

China People's Liberation Army No. Eight One Hospital

Zheling Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Qingdao Infectious Diseases Hospital

Zhiqiang zou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Yantai Infectious Diseases Hospital

Peili Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Third Hospital of Qinhuangdao City

Dexing Jia, Doctor

Role: PRINCIPAL_INVESTIGATOR

Weifang People's Hospital

Zhenghua Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tai'an Central Hospital

Feng Gao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Linyi People's Hospital

Sikui Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Liaocheng People's Hospital

lingdao Huo, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Taiyuan

Yuping Ma, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xi'an Eighth Hospital

Hongxu Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Luohe Central Hospital

Xu Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Other Identifiers

SW002

Identifier Type: -

Identifier Source: org_study_id