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

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ClinicalTrials.gov Identifier: NCT02412319
Recruitment Status : Unknown
Verified April 2015 by Shineway Pharmaceutical Co.,Ltd.
Recruitment status was:  Active, not recruiting
First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Shineway Pharmaceutical Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
HBeAg Positive Chronic Hepatitis B Drug: Anti-HBV placenta transfer factor injection Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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

Placebo Comparator: 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
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




Primary Outcome Measures :
  1. HBeAg serum conversion rate [ Time Frame: Week 48 ]
    The HBeAg serum conversion rate of the Test Group and the Control Group after 48 weeks treatment


Secondary Outcome Measures :
  1. HBeAg serum conversion rate [ Time Frame: Week 24, 72 ]
    The HBeAg serum conversion rate of the Test Group and the Control Group for treatment week 24, week 72

  2. HBeAg disappearance rate [ Time Frame: Week 24, 48 and 72 ]
    The HBeAg disappearance rate of the Test Group and the Control Group for treatment week 24, week 48 and week 72

  3. HBV DNA titer [ Time Frame: Week-4, 0,12,24,48,72 and 96 ]
    The proportion of subjects for each observation point in HBV DNA titer decreased 2 logarithmic

  4. The proportion of subjects for the HBV DNA can not be detected [ Time Frame: Week 24, 48 and 72 ]
    The proportion of subjects for the HBV DNA can not be detected in treatment week 24, week 48 and week 72

  5. HBeAg and HBsAg titer [ Time Frame: Week-4, 0,12,24,48,72 and 96 ]
    The changes of HBeAg and HBsAg titer at each observation point

  6. The quantitative changes of anti -HBc [ Time Frame: Week-4, 0,12,24,48,72 and 96 ]
    The quantitative changes of anti -HBc in each observation point

  7. The variation of ALT [ Time Frame: Week-4,24,48,72 and 96 ]
    The variation of ALT in each observation point

  8. The seroconversion rate of HBsAb and HBeAb [ Time Frame: Week-4, 0,12,24,48,72 and 96 ]
    The seroconversion rate of HBsAb and HBeAb in each observation point

  9. The resistance mutation rate of HBsAb and HBeAb [ Time Frame: Week-4, 0,12,24,48,72 and 96 ]
    The resistance mutation ncidence of HBsAb and HBeAb in each observation point

  10. The cumulative incidence of virologic breakthroughrate 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 in each observation point

  11. 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 ]
    The changes of relative immune parameters of the transfer factor in peripheral blood



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412319


Sponsors and Collaborators
Shineway Pharmaceutical Co.,Ltd
Investigators
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Study Chair: Guiqiang Wang, Doctor Peking University First Hospital
Principal Investigator: Maorong Wang, Doctor China People's Liberation Army No. Eight One Hospital
Principal Investigator: Zheling Wang, Doctor Qingdao Infectious Diseases Hospital
Principal Investigator: Zhiqiang zou, Doctor Yantai Infectious Diseases Hospital
Principal Investigator: Peili Zhao, Doctor The Third Hospital of Qinhuangdao City
Principal Investigator: Dexing Jia, Doctor Weifang People's Hospital
Principal Investigator: Zhenghua Zhao, Doctor Tai'an Central Hospital
Principal Investigator: Feng Gao, Doctor Linyi People's Hospital
Principal Investigator: Sikui Wang, Doctor Liaocheng People's Hospital
Principal Investigator: lingdao Huo, Doctor The Third People's Hospital of Taiyuan
Principal Investigator: Yuping Ma, Doctor Xi'an Eighth Hospital
Principal Investigator: Hongxu Zhang, Doctor Luohe Central Hospital
Principal Investigator: Xu Zhang, Doctor General Hospital of Ningxia Medical University

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Responsible Party: Shineway Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02412319     History of Changes
Other Study ID Numbers: SW002
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Keywords provided by Shineway Pharmaceutical Co.,Ltd:
HBeAg positive chronic hepatitis B
HBeAg serum conversion rate
HBeAg serum disappearance rate
HBeAg and HBsAg titer
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents