Overview

This trial is active, not recruiting.

Condition hbeag positive chronic hepatitis b
Treatments anti-hbv placenta transfer factor injection, placebo
Phase phase 4
Sponsor Shineway Pharmaceutical Co.,Ltd
Start date October 2014
End date December 2016
Trial size 288 participants
Trial identifier NCT02412319, SW002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
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
(Placebo Comparator)
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
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

Primary Outcomes

Measure
HBeAg serum conversion rate
time frame: Week 48

Secondary Outcomes

Measure
HBeAg serum conversion rate
time frame: Week 24, 72
HBeAg disappearance rate
time frame: Week 24, 48 and 72
HBV DNA titer
time frame: Week-4, 0,12,24,48,72 and 96
The proportion of subjects for the HBV DNA can not be detected
time frame: Week 24, 48 and 72
HBeAg and HBsAg titer
time frame: Week-4, 0,12,24,48,72 and 96
The quantitative changes of anti -HBc
time frame: Week-4, 0,12,24,48,72 and 96
The variation of ALT
time frame: Week-4,24,48,72 and 96
The seroconversion rate of HBsAb and HBeAb
time frame: Week-4, 0,12,24,48,72 and 96
The resistance mutation rate of HBsAb and HBeAb
time frame: Week-4, 0,12,24,48,72 and 96
The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb
time frame: Week-4, 0,12,24,48,72 and 96
The changes of relative immune parameters of the transfer factor in peripheral blood(the number of T lymphocytes and the expression levels of cytokines)
time frame: Week 0, 12, 24, 48, 72, 96

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title The Efficacy and Safety of the Anti Hepatitis B Placenta Transfer Factor Injection in the Treatment of HBeAg Positive Chronic Hepatitis B, Randomized, Double Blind, Placebo Controlled, Multi Center Clinical Trial
Principal investigator Maorong Wang, Doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Shineway Pharmaceutical Co.,Ltd.