Phase 2
N=360
Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00869778 ↗Enrolled (actual)
360
Serious AEs
1.7%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants With HBeAg Seroconversion at Endpoint . — 38.8; 28.6; 20.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- εPA-44 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chongqing Jiachen Biotechnology Ltd.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HBeAg Seroconversion at Endpoint . |
38.8; 28.6; 20.2 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76 |
8.6; 7.6; 1.7; 13.8; 12.6; 7.6 | — |
| SECONDARY The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale; |
29.3; 33.6; 27.7; 42.2; 48.7; 39.5 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76 |
9.5; 4.2; 6.7; 12.9; 8.4; 11.8 | — |
| SECONDARY The Proportion of Patients With Both Negative HBeAg and HBeAb; |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Proportion of Patients With Positive Anti-HBe |
15.5; 14.3; 10.9; 25.9; 26.1; 18.5 | — |
| SECONDARY Change From Baseline by Visit for HBeAg Titer |
11.5; -460.2; -278.7; -285.4; -725.2; -450.3 | — |
| SECONDARY The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale; |
12.9; 19.3; 13.4; 29.3; 31.1; 24.4 | — |
| SECONDARY The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml; |
7.8; 10.9; 5.9; 17.2; 17.6; 11.8 | — |
| SECONDARY Change From Baseline by Visit for Serum HBV DNA |
-176000000; -336000000; -129000000; -213000000; -362000000; -172000000 | — |
Summary
The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（HBV） vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
Eligibility Criteria
Inclusion Criteria
- Aged 18-65 years, male or female
- 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 100000 copies/ml;HBeAg (+),HBsAb(-); Alanine aminotransferase（ALT） within 2 to 10 times of ULN (upper limit of normal)
- HLA-A2 positive
- 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; prothrombin time(PT) elongation≤3 sec; Activated partial thromboplastin time（APTT） within normal value; Fasting blood glucose≤7.0mmol/L
- TSH within normal value
- AFP ≤20ng/ml
- Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
- Understands and signs ICF approved by EC
- Willing to comply with the study procedures and complete the study
Exclusion Criteria
- Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive
- Antibody of CMV IgM, EBV IgM or HIV is positive
- Antinuclear antibody titer>1:160
- Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
- 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.
- Has used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymic peptide,etc ) 6 months prior to the administration of study medication
- Has participated in any other drug clinical investigations within the past 3 months
- Has allergy habitus or has suspected allergy to study drug
- Female who is in pregnancy, in lactation or planning to become pregnant during the course of the study
- 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
- Has a history of organ transplant (except external corneal transplantation and hair transplantation)
- Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Data sourced from ClinicalTrials.gov (NCT00869778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.