NCT07384936尚未招募不适用
A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.
Fang Wang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月31日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- soluble fms-like tyrosine kinase-1(sFlt-1)
研究概览
简要总结
This study is an open-label, prospective investigation designed to enroll 100 high-risk pregnant subjects with preeclampsia (PE). Participants will be allocated in a 2:2:1 ratio to one of three groups: the Topefilgrastim 0.5mg/biweekly group, the Topefilgrastim 1mg/biweekly group, or the control group, based on investigator judgment and patient preference. The overall study consists of three parts: a screening period, a treatment period, and a follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study, be able to understand, and sign the informed consent form.
- •Aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
- •Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either:
- •A risk value of ≥1/100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1/PLGF ratio). (See Appendix for details)
- •Gestational weeks 11-13 at enrollment.
- •Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound).
排除标准
- •History of psychiatric disorder not adequately controlled by medication.
- •Unexplained vaginal bleeding at screening.
- •Known uterine malformation.
- •Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis.
- •Known proliferative retinopathy.
- •Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation.
- •Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium.
- •Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins/peptides derived from E. coli.
研究组 & 干预措施
Topefilgrastim 0.5mg Group
Experimental
干预措施: Topefilgrastim Injection (Drug)
Topefilgrastim 1mg Group
Experimental
干预措施: Topefilgrastim Injection (Drug)
Control Group
No Intervention
结局指标
主要结局
soluble fms-like tyrosine kinase-1(sFlt-1)
时间窗: Gestational weeks 11-13；15-17；24-28
placental growth factor(PLGF)
时间窗: Gestational weeks 11-13；15-17；24-28
sFlt-1/PLGF ratio
时间窗: Gestational weeks 11-13；15-17；24-28
次要结局
- Incidence of preeclampsia(From 11 weeks of pregnancy to 6 weeks postpartum)
- Incidence of early-onset preeclampsia(From 11 weeks of pregnancy to 6 weeks postpartum)
- Incidence of PE-associated Preterm Delivery(From 11 weeks of pregnancy to 6 weeks postpartum)
- Miscarriage rate(From 11 weeks of pregnancy to 6 weeks postpartum)
- Preterm birth rate(From 11 weeks of pregnancy to 6 weeks postpartum)
- Gestational age at delivery(From 11 weeks of pregnancy to 6 weeks postpartum)
- Neonatal birth weight(From 11 weeks of pregnancy to 6 weeks postpartum)
- Incidence of small for gestational age (SGA) neonates(From 11 weeks of pregnancy to 6 weeks postpartum)
- Admission rate to the neonatal ward(From 11 weeks of pregnancy to 6 weeks postpartum)
- NICU admission rate(From 11 weeks of pregnancy to 6 weeks postpartum)
- Adverse Events (AEs)(From 11 weeks of pregnancy to 6 weeks postpartum)
- Serious Adverse Events (SAEs)(From 11 weeks of pregnancy to 6 weeks postpartum)
- Frequency of Adverse Events(From 11 weeks of pregnancy to 6 weeks postpartum)
- Frequency of Serious Adverse Events(From 11 weeks of pregnancy to 6 weeks postpartum)
- Severity of Adverse Events(From 11 weeks of pregnancy to 6 weeks postpartum)
- Severity of Serious Adverse Events(From 11 weeks of pregnancy to 6 weeks postpartum)
- Fetal Death(From 11 weeks of pregnancy to 6 weeks postpartum)
- Perinatal Death(From 11 weeks of pregnancy to 6 weeks postpartum)
- Incidence of congenital malformations(From 11 weeks of pregnancy to 6 weeks postpartum)
- Body Temperature(From 11 weeks of pregnancy to 6 weeks postpartum)
- Pulse(From 11 weeks of pregnancy to 6 weeks postpartum)
- Respiratory Rate(From 11 weeks of pregnancy to 6 weeks postpartum)
- Blood Pressure(From 11 weeks of pregnancy to 6 weeks postpartum)
- Height(From 11 weeks of pregnancy to 6 weeks postpartum)
- Weight(From 11 weeks of pregnancy to 6 weeks postpartum)
- Number of Participants with Abnormal Laboratory Parameters Findings(From 11 weeks of pregnancy to 6 weeks postpartum)
- Number of subjects with clinically significant abnormal findings in radiological examinations(From 11 weeks of pregnancy to 6 weeks postpartum)
- Resistance Index (RI) of Uterine Spiral Arteries(Gestational weeks 11-13；15-17；24-28)
- Pulsatility Index (PI) of Uterine Arteries(Gestational weeks 11-13；15-17；24-28)
- Systolic to Diastolic Ratio (S/D ratio) of Uterine Spiral Arteries(Gestational weeks 11-13；15-17；24-28)
研究者
Fang Wang
Chief physician
Lanzhou University Second Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar CholangiocarcinomaNCT07326189Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University33
招募中
不适用
EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular InteractionsNCT07358026MELISA Institute Genomics & Proteomics Research SpA223
尚未招募
1 期
Pharmacokinetic Study to Evaluate Safety and Tolerability of EG-101 in Healthy Female Volunteers as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsiaPre-eclampsiaNCT07327255Evergreen Therapeutics, Inc.24
招募中
不适用
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)Complicating Pregnancy Pre-EclampsiaPre-eclampsiaMild Pre-EclampsiaNCT07263490Copenhagen University Hospital, Hvidovre462
招募中
不适用
A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in BoliviaPulmonary Arterial HypertensionIntrauterine Growth RestrictionNCT07312227Massachusetts General Hospital27