Therapeutic Hepatitis B Vaccine (Synthesized Peptide εPA-44) Joint Entecavir in Treating Chronic Hepatitis B Patients
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatments||therapeutic hbv vaccine, entecavir, empty liposome, entecavir|
|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|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Primary efficacy assessment is the serological conversion rate of HBeAg at week. 48
time frame: 48 weeks
time frame: 96 weeks
time frame: 96 weeks
time frame: 96 weeks
time frame: 72 weeks
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.
|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).|
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