Phase 2
Completed N=209
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Source: ClinicalTrials.gov NCT02862106 ↗Enrolled (actual)
209
Serious AEs
2.5%
Results posted
Jan 2017
Primary outcomePrimary: The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period — 66.7; 100; 100; 38.7 percentage of participants
Summary
The purpose is to evaluate efficacy and safety of therapeutic 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period |
66.7; 100; 100; 38.7; 40; 34.5 | — |
| SECONDARY The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 |
66.7; 100; 100; 25.8; 21.8; 34.5 | — |
| SECONDARY The Proportion of Patients With Both Negative HBeAg and HBeAb. |
33.3; 0; 0; 1.6; 0; 1.7 | — |
| SECONDARY The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Proportion of Patients With Both Negative HBsAg and HBsAb. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit |
100; 90.9; 100; 25.8; 30.9; 36.2 | — |
| SECONDARY Change From Baseline by Visit for Serum HBV DNA |
8.1; 7.6; 7.5; 7.8; 8.1; 8.0 | — |
| SECONDARY Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; |
100; 100; 100; 59.7; 52.7; 60.3 | — |
| SECONDARY Change From Baseline by Vsit for HBeAg Titer. |
1276.5; 758.5; 285.9; 681.9; 958.3; 880.9 | — |
Eligibility Criteria
Inclusion Criteria
- The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
- 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
1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Data sourced from ClinicalTrials.gov (NCT02862106). 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. Informational only — not medical advice.