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Sponsored by: |
Chongqing Jiachen Biotechnology Ltd. |
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Information provided by: | Chongqing Jiachen Biotechnology Ltd. |
ClinicalTrials.gov Identifier: | NCT00869778 |
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.
Condition | Intervention | Phase |
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Chronic Hepatitis B |
Biological: The therapeutic (synthesized peptide) HBV vaccine (εPA-44) Biological: Placebo |
Phase II |
Study Type: | Interventional |
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 |
Arms | Assigned Interventions |
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εPA-44 900μg: Experimental | Biological: The therapeutic (synthesized peptide) HBV vaccine (εPA-44) |
εPA-44 600μg: Experimental | Biological: The therapeutic (synthesized peptide) HBV vaccine (εPA-44) |
Placebo: Placebo Comparator | Biological: Placebo |
Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio:
The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yuzhang Wu | 86-23-68752680 | wuyuzhang@yahoo.com |
China | |
Hepatitis Institute of Peking University People's Hospital | Recruiting |
Beijing, China | |
Contact: Lai Wei 86-10-88325566 weelai@163.com | |
Principal Investigator: Lai Wei |
Study ID Numbers: | 71006.01 |
Study First Received: | March 25, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00869778 History of Changes |
Health Authority: | China: State Food and Drug Administration |
HBeAg positive Chronic Hepatitis B |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Hepadnaviridae Infections |