PreeclampsiaNCT07384936
Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia
A study testing Topefilgrastim Injection in people with Preeclampsia, run by Fang Wang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Topefilgrastim Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either:
- A risk value of ≥1/100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1/PLGF ratio). (See Appendix for details)
- Gestational weeks 11-13 at enrollment.
- Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound).
Who cannot join
- 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.
- Known proliferative retinopathy.
- Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation.
- Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium.
- Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins/peptides derived from E. coli.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.
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.
- Conditions
- Preeclampsia
- Being tested
- Topefilgrastim Injection
- Keywords
- Preeclampsia, Topefilgrastim Injection
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topefilgrastim InjectionDrug
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 InjectionDrug
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 group | Role | What they receive |
|---|---|---|
| Topefilgrastim 0.5mg Group | Experimental | Not described Receives: Drug: Topefilgrastim Injection |
| Topefilgrastim 1mg Group | Experimental | Not described Receives: Drug: Topefilgrastim Injection |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
soluble fms-like tyrosine kinase-1(sFlt-1)
Measured: Gestational weeks 11-13；15-17；24-28
placental growth factor(PLGF)
Measured: Gestational weeks 11-13；15-17；24-28
sFlt-1/PLGF ratio
Measured: Gestational weeks 11-13；15-17；24-28
Secondary outcomes (30)
Incidence of preeclampsia
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of early-onset preeclampsia
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of PE-associated Preterm Delivery
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Miscarriage rate
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Preterm birth rate
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Gestational age at delivery
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Neonatal birth weight
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of small for gestational age (SGA) neonates
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Admission rate to the neonatal ward
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
NICU admission rate
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Adverse Events (AEs)
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Serious Adverse Events (SAEs)
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Frequency of Adverse Events
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Frequency of Serious Adverse Events
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Severity of Adverse Events
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Severity of Serious Adverse Events
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Fetal Death
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Perinatal Death
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of congenital malformations
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Body Temperature
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Pulse
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Respiratory Rate
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Blood Pressure
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Height
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Weight
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Number of Participants with Abnormal Laboratory Parameters Findings
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Number of subjects with clinically significant abnormal findings in radiological examinations
including maternal/fetal or perinatal infants
Measured: From 11 weeks of pregnancy to 6 weeks postpartum
Resistance Index (RI) of Uterine Spiral Arteries
Measured: Gestational weeks 11-13；15-17；24-28
Pulsatility Index (PI) of Uterine Arteries
Measured: Gestational weeks 11-13；15-17；24-28
Systolic to Diastolic Ratio (S/D ratio) of Uterine Spiral Arteries
Measured: Gestational weeks 11-13；15-17；24-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-Initiated Trial (IIT)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fang Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Responsible party
- Sponsor-investigator, Fang Wang, Lanzhou University Second Hospital
- Investigators
- Fang Wang, Principal investigator, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384936
- Sponsor's protocol ID
- PG-5-1-005
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.
- ClinicalTrials.gov ID
- NCT07384936
- Acronym / sponsor ID
- PG-5-1-005
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Topefilgrastim Injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fang WangUniversity, hospital or other
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Investigator-Initiated Trial (IIT)
| Arm | Type | Receives |
|---|---|---|
| Topefilgrastim 0.5mg Group | Experimental | Drug: Topefilgrastim Injection |
| Topefilgrastim 1mg Group | Experimental | Drug: Topefilgrastim Injection |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either:
- A risk value of ≥1/100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1/PLGF ratio). (See Appendix for details)
- Gestational weeks 11-13 at enrollment.
Key exclusion criteria (8 listed)
- 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.
- Known proliferative retinopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topefilgrastim InjectionSubjects 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. | Drug | Topefilgrastim 0.5mg Group |
| Topefilgrastim InjectionSubjects 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. | Drug | Topefilgrastim 1mg Group |
Primary outcome
soluble fms-like tyrosine kinase-1(sFlt-1)
Time frame: Gestational weeks 11-13；15-17；24-28
placental growth factor(PLGF)
Time frame: Gestational weeks 11-13；15-17；24-28
sFlt-1/PLGF ratio
Time frame: Gestational weeks 11-13；15-17；24-28
30 secondary outcomes
Incidence of preeclampsia
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of early-onset preeclampsia
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of PE-associated Preterm Delivery
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Miscarriage rate
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Preterm birth rate
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Gestational age at delivery
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Neonatal birth weight
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of small for gestational age (SGA) neonates
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Admission rate to the neonatal ward
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
NICU admission rate
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Adverse Events (AEs)
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Serious Adverse Events (SAEs)
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Frequency of Adverse Events
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Frequency of Serious Adverse Events
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Severity of Adverse Events
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Severity of Serious Adverse Events
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Fetal Death
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Perinatal Death
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Incidence of congenital malformations
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Body Temperature
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Pulse
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Respiratory Rate
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Blood Pressure
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Height
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Weight
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Number of subjects with clinically significant abnormal findings in radiological examinations
Time frame: From 11 weeks of pregnancy to 6 weeks postpartum
Resistance Index (RI) of Uterine Spiral Arteries
Time frame: Gestational weeks 11-13；15-17；24-28
Pulsatility Index (PI) of Uterine Arteries
Time frame: Gestational weeks 11-13；15-17；24-28
Systolic to Diastolic Ratio (S/D ratio) of Uterine Spiral Arteries
Time frame: Gestational weeks 11-13；15-17；24-28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Wang principal investigator
Lanzhou University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topefilgrastim Injection in people with Preeclampsia, run by Fang Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wang (13919302888, ery_fwang@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soluble fms-like tyrosine kinase-1(sFlt-1) (time frame: Gestational weeks 11-13；15-17；24-28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.