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.

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 Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Topefilgrastim Injection; Drug: Topefilgrastim Injection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Wang; Phone Number: 13919302888; Email: ery_fwang@lzu.edu.cn

Study Locations

• China
  • Lanzhou, China
    • Lanzhou University Second Hospital
    • Contact: Fang Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Topefilgrastim 0.5mg Group	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.
Experimental: Topefilgrastim 1mg Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gestational age at delivery		From 11 weeks of pregnancy to 6 weeks postpartum
Neonatal birth weight		From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of small for gestational age (SGA) neonates		From 11 weeks of pregnancy to 6 weeks postpartum
Admission rate to the neonatal ward		From 11 weeks of pregnancy to 6 weeks postpartum
NICU admission rate		From 11 weeks of pregnancy to 6 weeks postpartum
Adverse Events (AEs)		From 11 weeks of pregnancy to 6 weeks postpartum
Serious Adverse Events (SAEs)		From 11 weeks of pregnancy to 6 weeks postpartum
Frequency of Adverse Events		From 11 weeks of pregnancy to 6 weeks postpartum
Frequency of Serious Adverse Events		From 11 weeks of pregnancy to 6 weeks postpartum
Severity of Adverse Events		From 11 weeks of pregnancy to 6 weeks postpartum
Severity of Serious Adverse Events		From 11 weeks of pregnancy to 6 weeks postpartum
Fetal Death		From 11 weeks of pregnancy to 6 weeks postpartum
Perinatal Death		From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of congenital malformations		From 11 weeks of pregnancy to 6 weeks postpartum
Body Temperature		From 11 weeks of pregnancy to 6 weeks postpartum
Pulse		From 11 weeks of pregnancy to 6 weeks postpartum
Respiratory Rate		From 11 weeks of pregnancy to 6 weeks postpartum
Blood Pressure		From 11 weeks of pregnancy to 6 weeks postpartum
Height		From 11 weeks of pregnancy to 6 weeks postpartum
Weight		From 11 weeks of pregnancy to 6 weeks postpartum
Number of Participants with Abnormal Laboratory Parameters Findings		From 11 weeks of pregnancy to 6 weeks postpartum
Number of subjects with clinically significant abnormal findings in radiological examinations	including maternal/fetal or perinatal infants	From 11 weeks of pregnancy to 6 weeks postpartum
Resistance Index (RI) of Uterine Spiral Arteries		Gestational weeks 11-13；15-17；24-28
Pulsatility Index (PI) of Uterine Arteries		Gestational weeks 11-13；15-17；24-28
Systolic to Diastolic Ratio (S/D ratio) of Uterine Spiral Arteries		Gestational weeks 11-13；15-17；24-28

Collaborators and Investigators

• Sponsor: Fang Wang
• Collaborators: Xiamen Amoytop Biotech Co., Ltd.
• Investigators: Principal Investigator: Fang Wang, Lanzhou University Second Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Preeclampsia; Topefilgrastim Injection
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: PG-5-1-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No