drugset / Trial / NCT07384936

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

NCT07384936 ↗

Not yet recruiting 100 enrolled Fang Wang Xiamen Amoytop Biotech Co., Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-31
Primary completion
2027-05
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Topefilgrastim Unknown 0.5 mg Subcutaneous
Subject Topefilgrastim Unknown 1 mg Subcutaneous

Indications