NCT07384936Not yet recruiting
Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia
A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 31 Jan 2026
- Primary completion date
- May 2027
- Lead sponsor
- Fang Wang
- NCT number
- NCT07384936
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 31 Jan 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium.
Other illness
- History of psychiatric disorder not adequately controlled by medication.
- Unexplained vaginal bleeding at screening.
- Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis.
- Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation.
- Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins/peptides derived from E. coli.
Other
- Known uterine malformation.
- Known proliferative retinopathy.
Who the study is looking for
- 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).
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.