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

N/ANot Yet RecruitingNCT07384936

Fang Wang100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Preeclampsia

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 InjectionDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lanzhou University Second Hospital

Lanzhou, China

Outcomes

Primary Outcomes

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