KOREAN POST MARKETING SURVEILLANCE FOR LITFULO CAPSULE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Frequency and proportion of AEs/ADRs
研究概览
简要总结
The purpose of this observation study is to learn about the safety and effects of the study medicine (called Litfulo) for the potential treatment of Severe Alopecia Areata.
详细描述
To evaluate the safety of Litfulo Capsule after marketing, with regard to the following clauses in routine clinical practice.
-
Adverse Events (AEs)/ Adverse Drug Reactions (ADRs)
-
Unexpected Adverse Events (AEs)/ADRs that have not been reflected in the approved drug label
-
Serious Adverse Events (SAEs)/Serious Adverse Drug Reaction (SADRs)
-
Adverse Event of Special Interest(AESI)
-
Serious Infections, defined as any infection (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy or hospitalization for treatment or meeting other criteria that require the infection to be classified as serious adverse event
-
Opportunistic infections and Herpes Zoster
-
Malignancy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe alopecia areata who have been determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product Treatment of severe alopecia areata in adults and adolescents 12 years or older Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study
排除标准
- 未提供
研究组 & 干预措施
Patients with severe alopecia areata.
Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product.
干预措施: Litfulo (Drug)
结局指标
主要结局
Frequency and proportion of AEs/ADRs
时间窗: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of unexpected AEs/ADRs
时间窗: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of SAEs/SADRs
时间窗: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of AESI
时间窗: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
次要结局
- Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48(24 weeks (Regular surveillance), 48 weeks (Long-term surveillance))
- Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48(24 weeks (Regular surveillance), 48 weeks (Long-term surveillance))
- Proportion of patients achieving 50% or above improvement in SALT score from baseline (SALT 50) at Weeks 24 and 48(24 weeks (Regular surveillance), 48 weeks (Long-term surveillance))
- Proportion of patients achieving 75% or above improvement in SALT score from baseline (SALT 75) at Weeks 24 and 48(24 weeks (Regular surveillance), 48 weeks (Long-term surveillance))