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Not yet recruiting NCT07384936

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

No phase Interventional Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topefilgrastim Injection, Topefilgrastim Injection.
Who it may be relevant to
Registry conditions: Preeclampsia. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.

Overview

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • soluble fms-like tyrosine kinase-1(sFlt-1) [Time frame: Gestational weeks 11-13；15-17；24-28]
  • placental growth factor(PLGF) [Time frame: Gestational weeks 11-13；15-17；24-28]
  • sFlt-1/PLGF ratio [Time frame: Gestational weeks 11-13；15-17；24-28]
Secondary outcome measures (12)
  • Incidence of preeclampsia [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Incidence of early-onset preeclampsia [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Incidence of PE-associated Preterm Delivery [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Miscarriage rate [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Preterm birth rate [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Gestational age at delivery [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Neonatal birth weight [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Incidence of small for gestational age (SGA) neonates [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Admission rate to the neonatal ward [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • NICU admission rate [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Adverse Events (AEs) [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]
  • Serious Adverse Events (SAEs) [Time frame: From 11 weeks of pregnancy to 6 weeks postpartum]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Lanzhou University Second Hospital — Lanzhou

Identifiers

NCT: NCT07384936 · PG-5-1-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗