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

HBeAg Positive Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02412319
• Other study ID #: SW002
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 10, 2015
• Last updated: April 5, 2015
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2015
• Source: Shineway Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 288
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HBeAg Positive Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shineway Pharmaceutical Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg serum conversion rate	The HBeAg serum conversion rate of the Test Group and the Control Group after 48 weeks treatment	Week 48	No
Secondary	HBeAg serum conversion rate	The HBeAg serum conversion rate of the Test Group and the Control Group for treatment week 24, week 72	Week 24, 72	No
Secondary	HBeAg disappearance rate	The HBeAg disappearance rate of the Test Group and the Control Group for treatment week 24, week 48 and week 72	Week 24, 48 and 72	No
Secondary	HBV DNA titer	The proportion of subjects for each observation point in HBV DNA titer decreased 2 logarithmic	Week-4, 0,12,24,48,72 and 96	No
Secondary	The proportion of subjects for the HBV DNA can not be detected	The proportion of subjects for the HBV DNA can not be detected in treatment week 24, week 48 and week 72	Week 24, 48 and 72	No
Secondary	HBeAg and HBsAg titer	The changes of HBeAg and HBsAg titer at each observation point	Week-4, 0,12,24,48,72 and 96	No
Secondary	The quantitative changes of anti -HBc	The quantitative changes of anti -HBc in each observation point	Week-4, 0,12,24,48,72 and 96	No
Secondary	The variation of ALT	The variation of ALT in each observation point	Week-4,24,48,72 and 96	No
Secondary	The seroconversion rate of HBsAb and HBeAb	The seroconversion rate of HBsAb and HBeAb in each observation point	Week-4, 0,12,24,48,72 and 96	No
Secondary	The resistance mutation rate of HBsAb and HBeAb	The resistance mutation ncidence of HBsAb and HBeAb in each observation point	Week-4, 0,12,24,48,72 and 96	No
Secondary	The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb	The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb in each observation point	Week-4, 0,12,24,48,72 and 96	No
Secondary	The changes of relative immune parameters of the transfer factor in peripheral blood(the number of T lymphocytes and the expression levels of cytokines)	The changes of relative immune parameters of the transfer factor in peripheral blood	Week 0, 12, 24, 48, 72, 96	No