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

ConditionPreeclampsia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFang Wang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the study, be able to understand, and sign the informed consent form.

Aged 18 to 45 years (inclusive) at the time of signing the informed consent form.

Gestational weeks 11-13 at enrollment.

Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound).

Disqualifiers

History of psychiatric disorder not adequately controlled by medication.

Unexplained vaginal bleeding at screening.

Known uterine malformation.

Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Topefilgrastim 0.5mg GroupExperimental treatment 1 intervention
Group B: Topefilgrastim 1mg GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

soluble fms-like tyrosine kinase-1(sFlt-1)

Time frame
Gestational weeks 11-13；15-17；24-28
2

placental growth factor(PLGF)

Time frame
Gestational weeks 11-13；15-17；24-28
3

sFlt-1/PLGF ratio

Time frame
Gestational weeks 11-13；15-17；24-28

Secondary outcomes

1

Incidence of preeclampsia

Time frame
From 11 weeks of pregnancy to 6 weeks postpartum
2

Incidence of early-onset preeclampsia

Time frame
From 11 weeks of pregnancy to 6 weeks postpartum
3

Incidence of PE-associated Preterm Delivery

Time frame
From 11 weeks of pregnancy to 6 weeks postpartum
4

Miscarriage rate

Time frame
From 11 weeks of pregnancy to 6 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fang Wang

Lead sponsor

Lanzhou University Second Hospital

Sponsor institution

Xiamen Amoytop Biotech Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: