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Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia
Sponsor: Fang Wang
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.
Official title: A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-01-31
Completion Date
2027-12
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Lanzhou University Second Hospital
Lanzhou, China