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
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
Treatments tested in this trial
- Topefilgrastim Injection
- Topefilgrastim Injection
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fang Wang
Lead sponsor
Lanzhou University Second Hospital
Sponsor institution
Xiamen Amoytop Biotech Co., Ltd.
Collaborator
Source ClinicalTrials.gov