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Starting soon Not applicable

Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia

NCT07384936 · tracked via the Priya Life Science China tracker
Sponsor
Fang Wang
Phase
Not applicable
Started
2026-01-31
Last updated
2026-02-03

Condition(s) studied

Preeclampsia

Investigational drug(s) / intervention(s)

Topefilgrastim InjectionTopefilgrastim Injection

Topefilgrastim Injection: Subjects will receive subcutaneous injection of 0.5 mg Topefilgrastim starting from Week 1 Day 1 (W1D1), with a frequency of once every two weeks, for at least 8 consecutive weeks.

Topefilgrastim Injection: Subjects will receive subcutaneous injection of 1 mg Topefilgrastim starting from Week 1 Day 1 (W1D1), with a frequency of once every two weeks, for at least 8 consecutive weeks.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Primary outcome measure(s)

  • soluble fms-like tyrosine kinase-1(sFlt-1) — Gestational weeks 11-13;15-17;24-28
  • placental growth factor(PLGF) — Gestational weeks 11-13;15-17;24-28
  • sFlt-1/PLGF ratio — Gestational weeks 11-13;15-17;24-28

Trial sites (1)

FacilityCityRegionStatus
Lanzhou University Second Hospital Lanzhou China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07384936 on ClinicalTrials.gov ↗ ← All trials in China