Therapeutic Hepatitis B Vaccine (Synthesized Peptide εPA-44) Joint Entecavir in Treating Chronic Hepatitis B Patients (THBVJEITCHBP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Chongqing Jiachen Biotechnology Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Third Military Medical University
Information provided by (Responsible Party):
Chongqing Jiachen Biotechnology Ltd.
ClinicalTrials.gov Identifier:
NCT01326546
First received: March 28, 2011
Last updated: June 12, 2012
Last verified: June 2012

March 28, 2011
June 12, 2012
June 2010
December 2012   (final data collection date for primary outcome measure)
Primary efficacy assessment is the serological conversion rate of HBeAg at week. 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01326546 on ClinicalTrials.gov Archive Site
  • Serological response [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Serological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg.
  • Virological response [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Virological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level <1.72×104 IU/ml.
  • Biochemistry response [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Biochemistry response at every observation time, mean the ALT level reduce to normal.
  • Histological response [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.
  • Secondary efficacy parameters include virology, response rate of each parameter should be calculated. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Virological response at every observation time.
  • Secondary efficacy parameters include serum parameters of patient, response rate of each parameter should be calculated. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Serological response at every observation time; Biochemistry response at every observation time, mean the ALT level reduce to normal.
  • Secondary efficacy parameters include histological response at week 72. [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.
Not Provided
Not Provided
 
Therapeutic Hepatitis B Vaccine (Synthesized Peptide εPA-44) Joint Entecavir in Treating Chronic Hepatitis B Patients
A Randomized, Double-blind, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Synthesized Peptide) Joint Entecavir in Treating HBeAg Positive Chronic Hepatitis B Patients

The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (synthesized peptide) Joint entecavir treatment in chronic hepatitis B patients.

Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio:

  1. Therapeutic HBV vaccine Joint Entecavir group:Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ;
  2. Empty liposome Joint Entecavir group:Inject empty liposome 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day.

The study cycle consists of screening and enrollment period (week -4~0), treatment and follow-up period (week 0-96).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Therapeutic HBV vaccine, entecavir
    Therapeutic HBV vaccine :900ug,per time,intramuscular injection; Entecavir:0.5mg,per day,oral intake.
  • Drug: Empty liposome, entecavir
    Empty liposome: 900ug,per time,intramuscular injection; Entecavir:0.5mg,per day,oral intake.
  • Active Comparator: Therapeutic HBV vaccine Joint Entecavir
    Therapeutic HBV vaccine Joint Entecavir group:Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
    Intervention: Drug: Therapeutic HBV vaccine, entecavir
  • Placebo Comparator: Empty liposome Joint Entecavir
    Placebo comparator: Inject placebo (empty liposome) 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
    Intervention: Drug: Empty liposome, entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
378
March 2013
December 2012   (final data collection date for primary outcome measure)

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), never have systemic treatment of anti-HBV viral ,and

    • HBV-DNA ≥ 1.72×104 IU/ml;
    • HBeAg (+), HBeAb (-);
    • 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 ≥ 3.5×109/L;
    • ANC ≥ 1.5×109/L;
    • PLT ≥ 80×109/L;
    • Hb ≥ 100g/L;
    • TBil ≤ 1.5 ULN;
    • ALB not lower than low limit of normal value;
    • BUN no more than high limit of normal value;
    • Cr ≤ 1.5 ULN high limit of 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 no more than high limit of normal value;
  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 HCV, HDV or HIV is positive;
  2. ANA titer > 1:100;
  3. Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);
  4. Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in 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: bronchiectasia, 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, metal, acute or chronic pancreatitis illness history, etc.
  5. Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;
  6. Have allergic diathesis or have suspected allergy to εPA-44;
  7. Female in pregnancy, lactation or those who plan to pregnancy during the course of the study;
  8. 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;
  9. Have history of organ transplantation (except corneal transplantation and hair transplantation);
  10. Have participated in any other drug clinical investigations within 3 months;
  11. Any other factors inappropriate for enroll in the study or study completion in the view of the investigator.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01326546
71006.04
Yes
Chongqing Jiachen Biotechnology Ltd.
Chongqing Jiachen Biotechnology Ltd.
Third Military Medical University
Not Provided
Chongqing Jiachen Biotechnology Ltd.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP