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

NCT02412319 | Unknown Phase 4 DMC

• 1 other identifier: SW002
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HBeAg Positive Chronic Hepatitis B

Keywords

HBeAg positive chronic hepatitis B; HBeAg serum conversion rate; HBeAg serum disappearance rate; HBeAg and HBsAg titer

Outcome Measures

Primary Outcomes (1)

• HBeAg serum conversion rate

  The HBeAg serum conversion rate of the Test Group and the Control Group after 48 weeks treatment

  Week 48

Secondary Outcomes (11)

• HBeAg serum conversion rate

  Week 24, 72

• HBeAg disappearance rate

  Week 24, 48 and 72

• HBV DNA titer

  Week-4, 0,12,24,48,72 and 96

• The proportion of subjects for the HBV DNA can not be detected

  Week 24, 48 and 72

• HBeAg and HBsAg titer

  Week-4, 0,12,24,48,72 and 96

Study Arms (2)

Experimental Group

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

Drug: Anti-HBV placenta transfer factor injection

Comparator Group

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

Other: Placebo

Interventions

Anti-HBV placenta transfer factor injection 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

Experimental Group

Placebo 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

Comparator Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65, sex not limited;
• 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；
• \* ULN (2 times the upper limit of normal value) \< ALT \<10 \* ULN (10 times the upper limit of normal value);;
• total bilirubin \<51μmol/L;
• hepatitis B virus resistance gene sequencing negative;
• agree in the process of the study, do not participate in any other clinical studies or other anti HBV therapy;
• 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.

You may not qualify if:

• 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.
• with liver disease acute exacerbation cause a transient liver function decompensation disease or baseline with clinical performance of decompensated liver disease;
• serum creatinine ≥1.5mg/dl (≥130μmol/l);
• the serum amylase \> 2 times the normal reference upper limit value;
• hemoglobin (male \<100g/L, female \<90g/L), white blood cell\< 3.5\* 109/L, platelet\< 60 \* 109/L;
• 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;
• 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;
• subjects with a history of alcoholism or drug abuse,investigators consider the subjects cannot comply with this protocol or affect the results analysis;
• pregnancy,lactation or female subjects plan to conceive or the companions of male subjects plan to conceive during the study
• months before the study medication used immunosuppressants,immunomodulators(thymosin alpha), cytotoxic drugs;
• months before the study medication used anti HBV drug therapy (interferon, Lamivudine, Adefovir, Entecavir and Telbivudine, Tenofovir,etc);
• plan or have had liver transplantation;
• received other study drug treatment within 3 months prior to screening;
• drug allergy history or allergic for Nucleoside or Nucleotide drug;
• the subjects non compliance with the protocol or subjects exist any situation which investigators considered not suitable for participation in this study.

Sponsors & Collaborators

• Shineway Pharmaceutical Co.,Ltd: lead

Study Officials

• Guiqiang Wang, Doctor

  Peking University First Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: April 9, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 9, 2015

Record last verified: 2015-04