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

Starting soon · Not applicable

Conditions studied: Preeclampsia

In brief

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.

Key facts

Study ID

NCT07384936

Run by

Fang Wang

People needed

100

Starts

2026-01-31

Expected to finish

2027-12-01

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Lanzhou University Second Hospital — Lanzhou, China

Full record on ClinicalTrials.gov

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