Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001
研究概览
简要总结
This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).
详细描述
This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study. In this ST-003 (OF-CALISTA) study, the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications [including Sodium Thiosulfate Injection and pain medication], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) will be recorded during an 8-week observation period following patient participation in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously enrolled as a patient in ST-001 CALISTA study
- •Willing to provide written informed consent
- •Willing and able to adhere to all study-related procedures
- •Willing to authorize release of medical records
- •Willing to authorize collection of medical data from health care providers
- •Provide email, home address and phone number where he/she can be reached
排除标准
- •Patient did not participate in ST-001 CALISTA study
结局指标
主要结局
Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001
时间窗: 8 weeks
Record the occurrence of delayed adverse events, standard of care treatments for calciphylaxis(medications \[including Sodium Thiosulfate Injection and pain medication\], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) following participation in ST-001
次要结局
未报告次要终点