A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*1301) for Susceptibility to Dapsone Hypersensitivity Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 3,130
- 试验地点
- 1
- 主要终点
- Incidence of clinically-suspected DHS during the 6-week observation period
研究概览
简要总结
This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a significantly lower incidence of immunologically-confirmed DHS versus current standard of care (no genetic screening or patch testing). The study consists of up to a 5-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the prospective Genetic Screening Arm will not receive dapsone and will be excluded from further study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration.
- •Subjects are dapsone-naive.
- •All subjects must have a clinical need for treatment with dapsone that precedes the decision to participate in the study.
- •All subjects are willing to complete the 6-weeks period clinical trial.
- •All subjects are written informed consent.
排除标准
- •Has previously received Dapsone therapy.
- •The subject or any of their healthcare providers is aware of the subjects HLA type.
- •Has been diagnosed with Glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency
- •Satisfies any contraindications or restrictions to Dapsone therapy as listed in the product labels.
- •Current severe illness, including heart, liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.
- •Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject's participation in the study [alanine aminotransferase (ALT), glutamic oxaloacetic transaminase(ALT), et al).
- •Pregnant women or women who are breastfeeding.
- •Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.
- •A positive result for HLA-B*1301 in those subjects randomised to the genetic screening arm.
研究组 & 干预措施
The prospective genetic screening arm
Prospective HLA-B*1301 screen before administrated treatment included dapsone
干预措施: Dapsone (Drug)
The prospective genetic screening arm
Prospective HLA-B*1301 screen before administrated treatment included dapsone
干预措施: HLA-B*1301 (Genetic)
The control arm
No HLA-B*1301 screen before administrated treatment included dapsone
干预措施: Dapsone (Drug)
结局指标
主要结局
Incidence of clinically-suspected DHS during the 6-week observation period
时间窗: 6 weeks
The primary outcome measure will be the total number of clinically suspected Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).
Incidence of immunologically-confirmed DHS during the 6-week observation period
时间窗: 6 weeks
The primary outcome measure will be the total number of immunologically confirmed Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).
次要结局
未报告次要终点