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

Sponsor
Fang Wang
Study ID
NCT07384936
Status
Not Yet Recruiting

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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Topefilgrastim Injection — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 3, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Topefilgrastim 0.5mg Group
  • Experimental: Topefilgrastim 1mg Group
  • No Intervention: Control Group

Primary Outcome Measure

soluble fms-like tyrosine kinase-1(sFlt-1) [ Time Frame: Gestational weeks 11-13；15-17；24-28 ]

Central Contacts

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