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

This study is ongoing, but not recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Therapeutic HBV vaccine, entecavir
Drug: Empty liposome, entecavir
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary efficacy assessment is the serological conversion rate of HBeAg at week. 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Enrollment: 378
Study Start Date: June 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Therapeutic HBV vaccine, entecavir
Therapeutic HBV vaccine :900ug,per time,intramuscular injection; Entecavir:0.5mg,per day,oral intake.
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.
Drug: Empty liposome, entecavir
Empty liposome: 900ug,per time,intramuscular injection; Entecavir:0.5mg,per day,oral intake.

Detailed Description:

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).

  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), 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326546

Locations
China, Zhejiang
Yida Yang
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
Chongqing Jiachen Biotechnology Ltd.
Third Military Medical University
  More Information

No publications provided

Responsible Party: Chongqing Jiachen Biotechnology Ltd.
ClinicalTrials.gov Identifier: NCT01326546     History of Changes
Other Study ID Numbers: 71006.04
Study First Received: March 28, 2011
Last Updated: June 12, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014