NCT02246595已完成2 期
A Phase II Randomized, Placebo-controlled, Double-blind, Dose Controlled Trial in Patients Suffering From Early, Newly Developing Abdominal or Pulmonary Derived Septic Organ Dysfunction to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and to Estimate Efficacy of the New Humanized Monoclonal i.v. Administered Antibody CaCP29
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- InflaRx GmbH
- 入组人数
- 72
- 试验地点
- 11
- 主要终点
- Plasma Concentration of CaCP29
研究概览
简要总结
The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •at screening:
- •Male or female patients >= 18 years old
- •Written informed consent
- •Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening
- •Suspected or confirmed abdominal or pulmonary infection at screening
- •Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection
- •At least one of the following acute organ dysfunctions due to sepsis. Each organ dysfunction must have occurred within 12 hours prior to screening, cannot mainly be explained by other disease processes than sepsis and is judged by the investigator as being caused or directly related to an abdominal or pulmonary infectious focus:
- •respiratory
- •hematologic
- •cardiovascular (occurred within the last three hours)
- •Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process
排除标准
- •at screening:
- •Sepsis of other primary cause than pulmonary or abdominal source
- •Weight > 130 kg at screening
- •Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
- •Patients receiving the following concomitant medication within 14 days prior to screening:
- •Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)
- •Proliferation inhibitors (e.g., everolimus, sirolimus)
- •Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)
- •High dose corticosteroids (e.g., > 50mg prednisolon per day or equivalent)
- •Patients receiving high dose immunoglobulins within 3 months prior to screening
- •Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count < 1,000/mm3 unless likely due to sepsis
- •General criteria:
- •Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
- •Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
- •Participation in any interventional clinical trial within the last three months
- •Prior participation in this clinical trial
- •Patient is chronically bed-bound prior to the onset of sepsis
- •Known intravenous drug abuse
- •Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
- •No commitment to full aggressive life support (e.g., do not resuscitate order)
- •Inclusion Criteria at randomisation:
- •At least one of the sepsis related organ dysfunction detected at screening is still present
- •Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing
- •Exclusion Criteria at randomisation:
- •Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours
- •Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours
- •Organ dysfunctions are unlikely to be persistent for next three hours
研究组 & 干预措施
Placebo
Placebo Comparator
dose escalation mimicing i.v. placebo treatment:
干预措施: Placebo (Biological)
CaCP29
Active Comparator
dose escalating i.v. administration of CaCP29 (verum)
干预措施: CaCP29 (Biological)
结局指标
主要结局
Plasma Concentration of CaCP29
时间窗: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28
Pharmacokinetic measures include * Plasma concentration over time * Maximum observed concentration per infusion * Concentration measured immediately before next dosing * Area under the curve of plasma concentration per infusion * Mean concentration per infusion * Terminal phase half-life
Assess the pharmacodynamic (PD) effects of CaCP29 on the change from baseline in plasma concentrations of C5a
时间窗: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28
Safety variables will be summarized using descriptive statistics based on adverse event collection
时间窗: 28 days
次要结局
- Change in routine laboratory parameters as compared to baseline(Days 1, 2, 3, 4, 5, 8, 13, 28)
- Change in vital signs as compared to baseline(Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28)
- All-cause mortality rate(28 days)
- Change in ECG as compared to baseline(Days 2, 4, 8, 28)
- Anti-drug antibodies (ADA)(28 days or hospital discharge)
- Morbidity(daily)
- Fluid balance(28 days or ICU discharge)
研究者
研究点 (11)
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