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Tests treatment safety and results for sFlt1 Mediated Preterm Preeclampsia
Official title A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Characteristics of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia and Their Children up to 24 Months
ClinicalTrials.gov ID: NCT07282171
What this study is testing
What is CBP-4888?
CBP-4888 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sflt1 mediated preterm preeclampsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant Management. Eligible participants are between 26 +0/7 and 35 +6/7 weeks gestational age and clinically appropriate for inpatient expectant management.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Hospitalized with a hypertensive disorder of pregnancy (preeclampsia) defined by elevated blood pressure after 20 weeks gestation with proteinuria...
- The subject has given written consent to participate in the study.
- Pregnant participants aged 18 to 45 years of age
- Gestational age at Day 1 between 26 weeks 0/7 days and 35 weeks 6/7 days
- Deemed clinically stable and suitable for expectant management for at least 72 hours post CBP-4888 administration
You likely can't join if
- Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding.
- Fetal growth restriction (\<3rd percentile, or \<10th percentile with abnormal Doppler) or known major chromosomal/genetic abnormalities.
- Maternal conditions requiring immediate delivery (e.g., severe hypertension, eclampsia, non-reassuring fetal status, pulmonary edema).
- Known active maternal infections considered to potentially affect placental function.
- Significant maternal medical conditions (e.g., HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder...
- Use of another investigational drug within 30 days prior to study entry.
See the full eligibility criteria
- Hospitalized with a hypertensive disorder of pregnancy (preeclampsia) defined by elevated blood pressure after 20 weeks gestation with proteinuria or, in the absence of proteinuria, with evidence of organ dysfunction...
- The subject has given written consent to participate in the study.
- Pregnant participants aged 18 to 45 years of age
- Gestational age at Day 1 between 26 weeks 0/7 days and 35 weeks 6/7 days
- Deemed clinically stable and suitable for expectant management for at least 72 hours post CBP-4888 administration
- The woman carries a singleton pregnancy
- Anticipate that hospitalization will continue through delivery
- Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding.
- Fetal growth restriction (\<3rd percentile, or \<10th percentile with abnormal Doppler) or known major chromosomal/genetic abnormalities.
- Maternal conditions requiring immediate delivery (e.g., severe hypertension, eclampsia, non-reassuring fetal status, pulmonary edema).
- Known active maternal infections considered to potentially affect placental function.
- Significant maternal medical conditions (e.g., HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder, lupus with nephritis/cerebritis).
- Use of another investigational drug within 30 days prior to study entry.
- Any other condition that, in the investigator's judgment, poses risk to mother or fetus.
The study team makes the final eligibility decision.
Where it's taking place
- Parkville, Victoria, Australia
- Melbourne, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Parkville, Victoria, Australia; Melbourne, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.