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Clinical Trials associated with Hepatitis B DNA vaccine(Guangzhou Baiyunshan Bai Di Bio-technology Co., Ltd.)治疗性双质粒HBV DNA疫苗治疗 HBeAg已发生血清学转换的慢性乙型肝炎的随机、双盲、对照、多中心Ⅱc期临床试验(方案B)
[Translation] A randomized, double-blind, controlled, multicenter phase IIc clinical trial of a therapeutic dual-plasmid HBV DNA vaccine for the treatment of chronic hepatitis B with HBeAg seroconversion (scheme B)
在完成Ⅱa期、Ⅱb期临床试验的基础上,评价治疗性双质粒HBV DNA疫苗治疗HBeAg已发生血清学转换、HBsAg阳性慢性乙型肝炎的有效性和安全性。
[Translation] Based on the completion of Phase IIa and Phase IIb clinical trials, the efficacy and safety of therapeutic dual-plasmid HBV DNA vaccine in the treatment of chronic hepatitis B with HBeAg seroconversion and HBsAg positivity were evaluated.
治疗性双质粒HBV DNA疫苗治疗 HBeAg未发生血清学转换的慢性乙型肝炎的随机、双盲、对照、多中心Ⅱc期临床试验 (方案A)
[Translation] A randomized, double-blind, controlled, multicenter phase IIc clinical trial of a therapeutic dual-plasmid HBV DNA vaccine for the treatment of chronic hepatitis B in patients without HBeAg seroconversion (Scheme A)
在完成Ⅱa期、Ⅱb期临床试验的基础上,评价治疗性双质粒HBV DNA疫苗治疗HBeAg未发生血清学转换的慢性乙型肝炎的有效性和安全性。
[Translation] Based on the completion of Phase IIa and Phase IIb clinical trials, the efficacy and safety of therapeutic dual-plasmid HBV DNA vaccine in the treatment of chronic hepatitis B in which HBeAg seroconversion has not occurred were evaluated.
A Randomized Controlled Trial of Dual-plasmid HBV DNA Vaccine Mediated by in Vivo Electroporation in Chronic Hepatitis B Patients Under Lamivudine Chemotherapy
In order to study the immunotherapeutic effects of electroporation (EP)-mediated dual-plasmids Hepatitis B Virus DNA vaccine, the investigators plan to conduct a double-blind, randomized, placebo-controlled trial, approved by Chinese State Food and Drug Administration with written informed consent from each chronic hepatitis B (CHB) patients with baseline ALT more than 2 times the ULN, for whom antiviral treatment is indicated and who were under the simultaneous lamivudine (LAM) chemotherapy.
Start Date01 Sep 2011 |
Sponsor / Collaborator- |
100 Clinical Results associated with Hepatitis B DNA vaccine(Guangzhou Baiyunshan Bai Di Bio-technology Co., Ltd.)
100 Translational Medicine associated with Hepatitis B DNA vaccine(Guangzhou Baiyunshan Bai Di Bio-technology Co., Ltd.)
100 Patents (Medical) associated with Hepatitis B DNA vaccine(Guangzhou Baiyunshan Bai Di Bio-technology Co., Ltd.)
100 Deals associated with Hepatitis B DNA vaccine(Guangzhou Baiyunshan Bai Di Bio-technology Co., Ltd.)