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Clinical Trials associated with BCG vaccine(Anhui Zhifei Longcom Biologic Pharmacy)Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG for Therapeutic Use in Preventing Postoperative Recurrence of Non-muscular Invasive Bladder Cancer in People Aged 18 and Over
This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.
评价治疗用卡介苗用于预防18周岁及以上人群非肌层浸润性膀胱癌术后复发的安全性和耐受性的I期临床试验
[Translation] A phase I clinical trial to evaluate the safety and tolerability of therapeutic BCG for preventing postoperative recurrence of non-muscle invasive bladder cancer in people aged 18 years and older
主要目的:评价治疗用卡介苗用于预防18周岁及以上人群非肌层浸润性膀胱癌术后复发的安全性和耐受性,为后续Ⅲ期临床试验的开展提供数据支持。次要目的:(1)评价评价治疗用卡介苗在18周岁及以上非肌层浸润性膀胱癌经尿道切除术后患者中的药代动力学(PK)特征;(2)考察治疗用卡介苗在18周岁及以上非肌层浸润性膀胱癌经尿道切除术后患者体内的脱落情况和免疫应答特征。
[Translation] Primary objective: To evaluate the safety and tolerability of therapeutic BCG for preventing postoperative recurrence of non-muscle invasive bladder cancer in people aged 18 years and above, and to provide data support for the subsequent Phase III clinical trial. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of therapeutic BCG in patients aged 18 years and above who have undergone transurethral resection for non-muscle invasive bladder cancer; (2) To investigate the shedding and immune response characteristics of therapeutic BCG in patients aged 18 years and above who have undergone transurethral resection for non-muscle invasive bladder cancer.
随机、盲法、安慰剂对照评价皮内注射用卡介苗(BCG)在6-65岁人群中接种的安全性和人体耐受性的I期临床试验
[Translation] A randomized, blinded, placebo-controlled Phase I clinical trial to evaluate the safety and human tolerability of intradermal Bacillus Calmette-Guérin (BCG) in people aged 6-65 years
主要目的: 评价试验用皮内注射用卡介苗在研究人群中应用的安全性和耐受性。 次要目的: 评价试验用皮内注射用卡介苗接种后机体84天、180天BCG-PPD、EC的阳转率。
[Translation] Primary objective: To evaluate the safety and tolerability of the experimental intradermal BCG vaccine in the study population. Secondary objective: To evaluate the positive conversion rate of BCG-PPD and EC 84 days and 180 days after the experimental intradermal BCG vaccine.
100 Clinical Results associated with BCG vaccine(Anhui Zhifei Longcom Biologic Pharmacy)
100 Translational Medicine associated with BCG vaccine(Anhui Zhifei Longcom Biologic Pharmacy)
100 Patents (Medical) associated with BCG vaccine(Anhui Zhifei Longcom Biologic Pharmacy)
100 Deals associated with BCG vaccine(Anhui Zhifei Longcom Biologic Pharmacy)