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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Chronic
Hepatitis, Chronic
Hepatitis B
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 September 22, 2014