Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments therapeutic hbv vaccine, entecavir, empty liposome, entecavir
Phase phase 2
Sponsor Chongqing Jiachen Biotechnology Ltd.
Collaborator Third Military Medical University
Start date June 2010
End date December 2012
Trial size 378 participants
Trial identifier NCT01326546, 71006.04

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
therapeutic hbv vaccine, entecavir
Therapeutic HBV vaccine :900ug,per time,intramuscular injection; Entecavir:0.5mg,per day,oral intake.
(Placebo Comparator)
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.
empty liposome, entecavir
Empty liposome: 900ug,per time,intramuscular injection; Entecavir:0.5mg,per day,oral intake.

Primary Outcomes

Measure
Primary efficacy assessment is the serological conversion rate of HBeAg at week. 48
time frame: 48 weeks

Secondary Outcomes

Measure
Serological response
time frame: 96 weeks
Virological response
time frame: 96 weeks
Biochemistry response
time frame: 96 weeks
Histological response
time frame: 72 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Chongqing Jiachen Biotechnology Ltd..