An Adaptive Multicentre, Randomized, Partially Double-blind, Placebo-controlled Study to Assess the Safety, PK and PD/Efficacy of RLX030 in Women With Pre-eclampsia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study
研究概览
简要总结
This study is designed in two parts. Part 1 will assess the safety and tolerability of different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can prolong pregnancy in women with pre-eclampsia.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
In part 1, equal number of subjects will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours in 3 cohorts.
In part 2, patients will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours
干预措施: Placebo (Drug)
RLX030
In part 1, within each cohort, two (2) patients per cohort will be treated open label with RLX030 and two (2) patients will be treated double blind with RLX030 as intravenous infusion for 72 hours. There will be 3 cohorts in part 1 with different doses of RLX030.
In part 2, there is no open label treatment on RLX030. In part 2, patients will be randomized in a double-blind fashion to this arm with the optimal dose of RLX030 as intravenous infusion for 72 hours as determined from part 1.
干预措施: RLX030 (Drug)
结局指标
主要结局
Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study
时间窗: Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)
Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.
Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile
时间窗: Randomization to delivery (maximum of 3 weeks)
Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)-Part 1
时间窗: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1
Blood concentrations of RLX-030 was assayed to determine this PK parameter.
Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1)
时间窗: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)
Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.
Decrease in Utero-placental Blood Flow (Part 1)
时间窗: During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)
Blood flow to the fetus was monitored using via a Doppler.
Number of Patients With Abnormalities in Birth Weight, Gestational Age, Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Score, Umbilical Cord Gases, and Days in Neonatal Intensive Care Unit (NICU)
时间窗: up to 4 - 6 weeks post partum (maximum of 8 weeks )
Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1
时间窗: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1
Blood concentrations of RLX-030 was assayed to determine this PK parameter.
Pharmacokinetics of RLX030: Mean Residence Time (MRT)
时间窗: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1
Blood concentrations of RLX-030 was assayed to determine this PK parameter.
Change From Baseline on Maternal Proteinuria (Part 1)
时间窗: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)
Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)
Improvement in Renal Function Assessed by Increase in Creatinine Clearance
时间窗: From randomization until 4-6 weeks post partum (maximum 8 weeks)
Rate of Spontaneous Delivery and/or Mode of Delivery
时间窗: From randomization to delivery (maximum of 3 weeks)
Number of Patients With Absence of Anti-serelaxin Antibodies
时间窗: From Randomization until 4-6 weeks post partum (maximum of 8 weeks)
Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1
时间窗: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1
Blood concentrations of RLX-030 was assayed to determine this PK parameter.
Change From Baseline in Mean Maternal Arterial Pressure (Part 1)
时间窗: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)
Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.
Change in Fetal Heart Rate (Part 1)
时间窗: During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)
Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph.
Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1
时间窗: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1
Blood concentrations of RLX-030 was assayed to determine this PK parameter.
次要结局
- Mean Number of Days Before Delivery(From randomization until delivery (maximum of 3 weeks))