εPA-44
Biologicalsubcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Other names: Therapeutic HBV vaccine
NCT Number: NCT02862106
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Renmin Hosptial of Wuhan University, Wuhan, Hubei, China
Second stage(76-144 weeks):
In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)
The definition of response as below:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Other names: Therapeutic HBV vaccine
Time frame: Endpoint (LOCF), up to 144 weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Time frame: week95,108,120,144
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
Chongqing Jiachen Biotechnology Ltd.
Industry
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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