NCT07384936

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fang Wang · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China