Non-interventional Real-World Study of Oteseconazole in the Treatment of Vulvovaginal Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- The proportion of subjects achieving clinical cure at 6-month,
研究概览
简要总结
Oteseconazole is a novel, oral, highly selective inhibitor of fungal CYP51. Oteseconazole showed statistically significant and clinically meaningful treatment of severe VVC and was generally tolerated. The trial is a national multi-center, non-interventional observational real-world study, aiming to evaluate the effecacy and safety of oteseconazole in the treatment of patients with VVC. This study will include patients with severe vulvovaginal candidiasis (SVVC) . It is divided into prospective and retrospective parts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old, female; vulvovaginal signs and symptoms (VSS) score ≥7; Plan to use oteseconazole monotherapy or combination therapy
排除标准
- •Evidence has shown that the patient whohas been pregnant or lactating; Patients who are participating in or planning to participate in other interventional clinical studies; Other situations determined by the researcher as unsuitable for inclusion in the study
研究组 & 干预措施
Oteseconazole
Subjects with SVVC will be treated with 600 mg (150 mg per capsule) on D1, 450 mg on D2
干预措施: Oteseconazole (VT-1161) 150mg capsule (Drug)
结局指标
主要结局
The proportion of subjects achieving clinical cure at 6-month,
时间窗: 6-month after the end of treatment
clinical cure，defined as the absence of signs and symptoms of VVC
次要结局
- The time of the first clinical recurrence of VVC during the follow-up period(From enrollment to the end of treatment for 3 years")
- The proportion of patients with clinical recurrence within 1-month, 12-month, 24-month and 36-month after treatment with Oteseconazole(1-month, 12-month, 24-month and 36-month after the end of treatment)
- Adverse events and serious adverse events from the time of signed consent to the end of the study(From enrollment to the end of treatment at 3 years)
研究者
Qinping Liao
Chief physician
Beijing Tsinghua Chang Gung Hospital