A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 12
- 主要终点
- Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV
详细描述
This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW (Cohorts 1 to 4) in adult and pediatric subjects with AdV viremia, and IV BCV in subjects with CMV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 2 months and older at the time of informed consent.
- •AdV DNA viremia >10,000 copies/mL from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies/mL, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to Day 1 (AdV DNA viremia results collected within the 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval) . CMV viremia with or without evidence of tissue invasive CMV disease. For laboratory results that are generated in units other than copies/mL or IU/mL, please refer to the testing laboratory for guidance on the appropriate conversion calculation.
- •Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.
- •In the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for AdV.
排除标准
- •Subjects who weigh ≥120 kg.
- •NIH/NCI CTCAE (United States [US] National Institutes of Health [NIH]/National Cancer Institute) Grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per day over usual pre-transplant stool output) within 7 days prior to Day
- •NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day
- •NIH Stage 2 or higher acute GVHD of the liver function (i.e., bilirubin >3 mg/dL [SI: >51 μmol/L]) within 7 days prior to Day
- •NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea >556 mL/m2/day for pediatric subjects [or >1000 mL/day for young adults as applicable, at centers in the United States only], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
研究组 & 干预措施
BCV 0.2mg/kg BIW
BCV: 0.2 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
BCV 0.3mg/kg BIW
BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
BCV 0.4 mg/kg BIW
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
BCV 0.4 mg/kg QW
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
0.4 mg/kg BIW
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
0.5 mg/kg BIW
BCV: 0.5 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
0.6 mg/kg BIW
BCV: 0.6 mg/kg administered as a continuous IV infusion over 2 hours
干预措施: BCV (Drug)
结局指标
主要结局
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
时间窗: From initiation of BCV administration up to 19 weeks
Safety will be evaluated based on incidence and severity of Adverse Events, Serious Adverse Events and laboratory assessments.
Antiviral Effects
时间窗: From initiation of BCV administration up to 9 weeks
Change from baseline AdV viremia in plasma measured on Day 1 and weekly throughout the study.
次要结局
未报告次要终点