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Therapeutic Hepatitis B Vaccine (Synthesized Peptide) in Treating Chronic Hepatitis B Patients
This study is currently recruiting participants.
Verified by Chongqing Jiachen Biotechnology Ltd., March 2009
First Received: March 25, 2009   No Changes Posted
Sponsored by: Chongqing Jiachen Biotechnology Ltd.
Information provided by: Chongqing Jiachen Biotechnology Ltd.
ClinicalTrials.gov Identifier: NCT00869778
  Purpose

The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (synthesized peptide) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.


Condition Intervention Phase
Chronic Hepatitis B
Biological: The therapeutic (synthesized peptide) HBV vaccine (εPA-44)
Biological: Placebo
Phase II

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines
U.S. FDA Resources
Study Type: Interventional
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Synthesized Peptide) in Treating Chronic Hepatitis B Patients

Further study details as provided by Chongqing Jiachen Biotechnology Ltd.:

Primary Outcome Measures:
  • Primary efficacy assessment is the change of HBV DNA level in patient serum HBV DNA at week 76:

Secondary Outcome Measures:
  • Secondary efficacy parameters include virological response rate at week 12,28,32,40,52,64 and serological response rate at week 12, 28, 32, 40, 52, 64, 76.

Arms Assigned Interventions
εPA-44 900μg: Experimental Biological: The therapeutic (synthesized peptide) HBV vaccine (εPA-44)
εPA-44 600μg: Experimental Biological: The therapeutic (synthesized peptide) HBV vaccine (εPA-44)
Placebo: Placebo Comparator Biological: Placebo

Detailed Description:

Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio:

  1. εPA-44 600μg group:Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28;
  2. εPA-44 900μg group:Subcutaneous inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28;
  3. Placebo control group:Subcutaneous inject empty liposome at week 0, 4, 8, 12, 20, 28;

The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-65 years, male or female
  2. Conforming to diagnosis standard of chronic hepatitis B according to"2005 Guideline for Prevention and Treatment of Hepatitis B", (with positive HBsAg for more than 6 months), and HBV-DNA more than 1×10E5 copies/ml;HBeAg (+), HBsAb(-);ALT within 2 to 10 times of ULN (upper limits of normal)
  3. HLA-A2 positive
  4. Compensatory liver disease having following hematological and biochemical parameters:WBC≥3.5×10E9/L;ANC≥1.5×10E9/L;PLT≥80×10E9/L;Hb≥110g/L;TBil≤1.5ULN;ALB in normal value;BUN,Cr in normal value;PT elongation≤3 sec;APTT in normal value;Fasting blood glucose≤7.0mmol/L
  5. TSH in normal value
  6. AFP test result ≤20ng/ml
  7. Take effective contraception for subject with child-bearing potential (including females and female partners of males)
  8. Understand and sign ICF approved by EC
  9. Willing to comply with the study procedures and complete the study

Exclusion Criteria:

  1. Antibodies of HAV IgM, HCV, HDV or HEV is positive
  2. Antibodies of CMV IgM, EBV IgM or HIV is positive
  3. ANA titer>1:160
  4. Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
  5. Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, such as:Cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc.;Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.;Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc.;Others: autoimmune disorder, active tuberculosis, malignancies (e.g.tumor), neuropathic or metal illness history,etc.
  6. Have used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymopeptides, etc ) 6 months prior to the administration of study medication
  7. Have participated in any other drug clinical investigations within 3 months
  8. Have allergy habitus or have suspected allergy to study drug
  9. Female in pregnance, lactation or those who plan to pregnancy during the course of the study
  10. Have history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence;
  11. Have history of organ transplantation (except corneal transplantation and hair transplantation);
  12. Any other factors inappropriate for enroll in the study or study completion in the view of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869778

Contacts
Contact: Yuzhang Wu 86-23-68752680 wuyuzhang@yahoo.com

Locations
China
Hepatitis Institute of Peking University People's Hospital Recruiting
Beijing, China
Contact: Lai Wei     86-10-88325566     weelai@163.com    
Principal Investigator: Lai Wei            
Sponsors and Collaborators
Chongqing Jiachen Biotechnology Ltd.
  More Information

No publications provided

Study ID Numbers: 71006.01
Study First Received: March 25, 2009
Last Updated: March 25, 2009
ClinicalTrials.gov Identifier: NCT00869778     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Chongqing Jiachen Biotechnology Ltd.:
HBeAg positive Chronic Hepatitis B

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009