Pharmacokinetics Of Emulsified Avacopan In ANCA-associated Vasculitis With Severe Diffuse Alveolar Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Avacopan blood level over time
研究概览
简要总结
The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for respiratory support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA).
- •Positivity for ANCA, directed against PR3 or MPO.
- •Diffuse alveolar hemorrhage.
- •Respiratory failure requiring mechanical ventilation.
- •Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.
- •Minimum BVAS-WG of
- •Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA).
排除标准
- •Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference.
- •Allergies: History of severe allergic reaction to avacopan
- •History of documented anti-glomerular basement membrane disease (anti-GBM disease)
- •Previous administration of avacopan within the last 5 days.
- •Concomitant use of a strong CYP3A4 inhibitor.
- •Aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphatase, or total bilirubin elevation >2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan.
- •Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection.
- •Active serious infection, including localized infection.
- •Pregnancy and breastfeeding
研究组 & 干预措施
Avacopan
Subjects will receive solubilized avacopan at a dose of 30 mg twice daily for 3 consecutive days, applied via NG tube.
干预措施: Avacopan (Drug)
结局指标
主要结局
Change in Avacopan blood level over time
时间窗: 72 hours
The primary objective of this study is to determine the blood (serum) level changes of Avacopan over time (pharmacokinetics) when Avacopan capsules are solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogastric tube. Blood will be drawn pre-dose, post-dose 30 minutes, 1-hour, 2-hour, 4-hour, and 6-hour for the first dose and pre-dose for the remaining 72 hours and stored for analysis.
次要结局
- Measure in Markers of Neutrophil Activation on Serum Samples(72 hours)
研究者
Ulrich Specks, MD
Principal Investigator
Mayo Clinic