A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of FP-1201 (Recombinant Human Interferon Beta) in the Treatment of Patients With Acute Lung Injury and Acute Respiratory Distress Syndrome.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Clinically Significant Treatment Emergent Events
研究概览
简要总结
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
详细描述
This was a phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of FP-1201 (IFN β-1a) in the treatment of patients with ALI and ARDS.
The primary objective in the study was to evaluate the safety and tolerability of FP-1201 in patients with ALI/ARDS and to assess the safety, tolerability and preliminary efficacy of the optimum tolerated dose (OTD) in patients likely to derive clinical benefit.
The study consisted of a dose escalation phase to determine the maximum tolerated dose (MTD) and OTD followed by a separate cohort expansion phase in which the OTD was administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult male or female patients with ALI/ARDS confirmed by the combination of the following diagnostic criteria:
- •An initiating clinical condition (e.g. sepsis, pneumonia, aspiration pneumonia, pancreatitis etc.)
- •Acute onset
- •Bilateral infiltrates documented by chest radiograph at end-aspiratory position
- •The absence of clinical evidence of left atrial hypertension
- •ALI: partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ratio ≤300 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <40kPa)
- •ARDS: PaO2 /FiO2 ≤200 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <26.7kPa)
- •Provision of signed written informed consent from the patient or patients legally authorized representative.
- •Age greater than or equal to
- •Initiation of study drug within 48 hours of the diagnosis of ALI/ARDS.
- •All patients at entry are required to be receiving mechanical ventilatory support.
- •Only patients who are considered suitable for active life support should be enrolled in the study.
- •No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates; if measured the pulmonary arterial wedge pressure should be less than or equal to 18mmHg
排除标准
- •Patients with burns.
- •Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- •Patients with significant Chronic Obstructive Pulmonary Disease requiring ongoing treatment e.g. chronic use of oxygen or ventilatory support at home prior to admission.
- •Patients with primary lung cancer or the presence of secondary metastases in the lungs.
- •Patients requiring treatment for congestive heart failure.
- •Patients receiving renal dialysis therapy for chronic renal failure.
- •Patients taking immunomodulatory therapy or oral steroids on admission.
- •Prior use of interferon.
- •Inability to maintain blood pressure to ensure adequate end organ perfusion. It should be noted that the use of plasma colloids or vasopressor agents is allowed to achieve the maintenance of blood pressure.
- •Current participation in another experimental treatment protocol.
研究组 & 干预措施
Interferon Beta
Interferon Beta
干预措施: Interferon Beta (Drug)
结局指标
主要结局
Clinically Significant Treatment Emergent Events
时间窗: From first dose up until Day 28
Treatment-emergent adverse events (TEAEs) in safety population
All Cause Mortality at Day 28
时间窗: 28 days following commencement of therapy
The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment
次要结局
- All Cause Mortality Rate at 6 Months(6 months following commencement of therapy)