A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 594
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period
研究概览
简要总结
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
详细描述
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subjects > or = 18 years of age and able to give informed consent
- •Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
- •Screening Visit laboratory Hgb indicative of anemia
- •Screening Visit ferritin indicative of iron deficiency anemia
排除标准
- •Known hypersensitivity to VIT-45
- •Previously received VIT-45
- •Parenteral iron in the 4 weeks prior to screening
- •Chronic or serious active infection
- •Malignancy history
- •Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
- •Anticipated need for surgery or initiation of dialysis during the study
- •Pregnant or sexually active females who are not willing to use an effective form of birth control
研究组 & 干预措施
VIT-45 on Day 0, then Placebo on Day 7
Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
Day 7: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
干预措施: VIT-45 (Drug)
VIT-45 on Day 0, then Placebo on Day 7
Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
Day 7: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
干预措施: Placebo (Drug)
Placebo on Day 0, then VIT-45 on Day 7
Day 0: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
干预措施: VIT-45 (Drug)
Placebo on Day 0, then VIT-45 on Day 7
Day 0: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period
时间窗: Day 0 to 7
Number of participants with any treatment-emergent adverse events experienced by participants. The 7-day study period for Study Period 1 ended with the initiation of dosing for Study Period 2. The 7-day study period fo Study Period 2 ended with the completion of Day 14 procedures.
次要结局
未报告次要终点