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NOT YET RECRUITING
NCT07384936
NA

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

Sponsor: Fang Wang

View on ClinicalTrials.gov

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

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.

Locations (1)

Lanzhou University Second Hospital

Lanzhou, China