A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Mean Change in Protein C Levels From Day 1 to Day 7
研究概览
简要总结
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.
Note: The protocol was amended to remove the option of shorter infusion durations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Must be 18 years or older
- •Must have a suspected or proven infection
- •Must have two or more sepsis-associated organ dysfunctions
排除标准
- •Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
- •Actual body weight less than 30 kg or more than 135 kg
- •Platelet count less than 30,000/mm^3
- •Active internal bleeding or at increased risk of bleeding
- •Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition
研究组 & 干预措施
Standard therapy
24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
干预措施: Drotrecogin alfa (activated) (Drug)
Alternative therapy:moderate protein C deficiency
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)
干预措施: Drotrecogin alfa (activated) (Drug)
Alternative therapy:severe protein C deficiency
24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)
干预措施: Drotrecogin alfa (activated) (Drug)
结局指标
主要结局
Mean Change in Protein C Levels From Day 1 to Day 7
时间窗: Day 1, Day 7
Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.
次要结局
- Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency(Day 1, Day 7)
- Day 28 All-Cause Mortality(Day 0 through Day 28)
- Hospital Mortality (up to Day 90)(Day 0 to hospital discharge or Day 90)
- 28-Day Time Averaged Sequential Organ Failure (SOFA) Score(Day 0, Day 28)
- Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period(Day 0 through Day 28)
- Mortality by Protein C Normalized Versus Not-normalized(28 days)