NCT07384936

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

January 19, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

January 19, 2026

Last Update Submit

January 26, 2026

Conditions

Preeclampsia

Keywords

PreeclampsiaTopefilgrastim Injection

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (30)

  • 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

  • +25 more secondary outcomes

Study Arms (3)

Topefilgrastim 0.5mg Group

EXPERIMENTAL
Drug: Topefilgrastim Injection

Topefilgrastim 1mg Group

EXPERIMENTAL
Drug: Topefilgrastim Injection

Control Group

NO INTERVENTION

Interventions

Topefilgrastim InjectionDRUG

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 0.5mg Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, China

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Fang Wang

    Lanzhou University Second Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Wang

CONTACT

13919302888ery_fwang@lzu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Investigator-Initiated Trial (IIT)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 3, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

CN(1)