Therapeutic Hepatitis B Vaccine (Synthesized Peptide) in Treating Chronic Hepatitis B Patients
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatments||the therapeutic (synthesized peptide) hbv vaccine (εpa-44), placebo|
|Sponsor||Chongqing Jiachen Biotechnology Ltd.|
|Collaborator||Third Military Medical University|
|Start date||June 2009|
|End date||March 2013|
|Trial size||360 participants|
|Trial identifier||NCT00869778, 71006.01|
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (synthesized peptide) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Primary efficacy assessment is the proportion of patients about HBeAg / anti-HBe seroconversion at the end of the follow-up period.
time frame: week 76, week 144
Secondary efficacy parameters include serology response at week 12, 28, 32, 40, 52, 64,76, 95,108, 120, 144.
time frame: week 12, 28, 32, 40, 52, 64, 76, 95,108, 120, 144
Virological response at each observation time point at week 12, 28, 32, 40, 52, 64, 76.
time frame: week 12, 28, 32, 40, 52, 64, 76
Biochemistry response at every observation point.
time frame: week 12, 28, 32, 40, 52, 64, 76
Virological response at each observation time point at week 95, 108, 120, 144.
time frame: Week 95, 108, 120, 144
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: 1. Aged 18-65 years, male or female 2. Conforms 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), and HBV-DNA more than 1.0E+5 copies/ml;HBeAg (+),HBsAb(-); 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 indicators:WBC≥3.5E+9/L; ANC≥1.5E+9/L; PLT≥80E+9/L; Hb≥110g/L; TBil≤1.5ULN; ALB ≥ lower limit of normal value; BUN (Urea)≤upper limit of normal value; Cr≤upper limit of normal value; PT elongation≤3 sec; APTT within normal value; Fasting blood glucose≤7.0mmol/L 5. TSH within normal value 6. AFP ≤20ng/ml 7. Uses effective contraception for subject with child-bearing potential (including females and female partners of males) 8. Understands and signs ICF approved by EC 9. Willing to comply with the study procedures and complete the study Exclusion Criteria: 1. Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive 2. Antibody of CMV IgM, EBV IgM or HIV is positive 3. Antinuclear antibody titer＞1:160 4. Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis 5. Has any of the following illnesses or has a severe disease inappropriate for participation in the study based on the investigator's judgment, such as: 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: bronchiectasis, 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 or metal illness history,etc. 6. Has used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymopeptides, etc ) 6 months prior to the administration of study medication 7. Has participated in any other drug clinical investigations within the past 3 months 8. Has allergy habitus or has suspected allergy to study drug 9. Female who is in pregnancy, in lactation or planning to become pregnant during the course of the study 10. Has a 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 11. Has a history of organ transplant (except external corneal transplantation and hair transplantation) 12. Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
|Official title||A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Synthesized Peptide) in Treating Chronic Hepatitis B Patients|
|Description||First stage(0-76 weeks): Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio： 1. εPA-44 600μg group：Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28. 2. εPA-44 900μg group：Subcutaneous inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28. 3. Placebo control group：Subcutaneous inject empty liposome at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28. The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76). Second stage(76-144 weeks): According to this follow-up stage, open designed, the subjects completed the first stage study(0-76 weeks): 1. If no virological response and no serological response, and refuse to continue the follow-up study, will be provided domestic Adefovir Dipivoxil for one year freely; 2. If have virological response but no serological response/have serological response but no virological response/neither virological nor serological response, and be willing to continue the follow-up study, will be treated by εPA-44 900 μg； 3. If have both virological and serological response, will be observed to 144 weeks. The definition of response as below: 1. Virological response: HBV DNA＜2.93×103IU/ml at 76 weeks; 2. Serological response: HBeAg appears to serological conversion at 76 weeks.|
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