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

Fang Wang

Status

Not yet enrolling

Conditions

Preeclampsia

Treatments

Drug: Topefilgrastim Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07384936

PG-5-1-005

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.