drugset / Trial / NCT07384936
Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Topefilgrastim | Unknown | 0.5 mg | Subcutaneous |
| Subject | Topefilgrastim | Unknown | 1 mg | Subcutaneous |