EUCTR2017-001735-39-IT进行中（未招募）1 期
An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients - AdAPT: Adenovirus after Allogeneic Pediatric Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 141
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Aged at least 2 months and less than 18-years-old on Day 1.
- •Have received a T cell-depleted allogeneic HCT within the previous 100 days.
- •First detectable AdV DNA plasma viremia since the qualifying transplant occurred within 21 days prior to Day 1.
- •AdV DNA plasma viremia = 1000 copies/mL and rising, defined as two consecutive results = 1000 copies/mL from the designated central virology laboratory, with the second result being greater than the first.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 141
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any CTCAE Grade 4 diarrhea (i.e., life-threatening consequences with urgent intervention indicated) within 7 days prior to Day 1.
- •Any CTCAE Grade 2 or 3 diarrhea (i.e., increase of = 4 stools per day over baseline), unless attributed to AdV, within 7 days prior to Day 1.
- •NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
- •NIH Stage 2 or higher acute GVHD of the liver (i.e., bilirubin > 3 mg/dL [SI: > 51 µmol/L]) within 7 days prior to Day 1.
- •NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 556 mL/m2/day, or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
- •Active malignancy (with the exception of non-melanoma skin cancer), including relapse or progression of the underlying disease for which qualifying transplant was performed.
- •Use of vasopressors within 7 days prior to Day 1.
- •PT-INR > 2x upper limit of normal reference range (ULN) in the absence of anticoagulation within 7 days prior to Day 1.
- •Requirement for mechanical ventilation within 7 days prior to Day 1, or sustained oxygen delivery for > 24 hours within 7 days prior to Day 1, or any oxygen requirement within 48 hours prior to Day 1.
- •Estimated creatinine clearance < 30 mL/min or use of renal replacement therapy (e.g., hemodialysis, continuous renal replacement therapy, peritoneal dialysis) within 7 days prior to Day 1.
- •ALT > 5x ULN, AST > 5x ULN, or total bilirubin > 3 mg/dL [SI: > 51 µmol/L] within 7 days prior to Day 1.
- •Human immunodeficiency virus (HIV) infection as detected through any laboratory method (e.g., enzyme-linked immunosorbent assay, Western Blot, RNA PCR). [Note: Testing to confirm the absence of HIV infection is required at screening unless testing was performed by the local laboratory within 6 months prior to screening.].
- •Females who are pregnant or breastfeeding or planning to become pregnant within 90 days after their last anticipated dose of BCV.
- •Receiving or anticipated to receive medications prohibited in this protocol (see Section 8.6.1).
- •Hypersensitivity (not including renal dysfunction or eye disorder) to CDV or to BCV or its formulation excipients.
- •Participation in another interventional clinical trial unless prior approval has been received from the Chimerix Medical Monitor (or designee) (see Section 8.6.1.3).
- •Received any cell-based anti-AdV therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.
研究者
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