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.
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.
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