Complement Regulation to Undo Systemic Harm in Preeclampsia

What is the Purpose of this Study?

This study focuses on pregnant women (between 23 and 30 weeks) who have been diagnosed with preeclampsia. The purpose of the study is to determine whether an investigational drug called eculizumab is an effective treatment for preeclampsia. Specifically, researchers will evaluate whether treatment with eculizumab prolongs pregnancy in women with preterm preeclampsia, compared to a group of women (historical control group) with preterm preeclampsia who did not receive eculizumab.

Eculizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain blood disorders and has been used in pregnant women, but it is not approved by the FDA for the treatment of preeclampsia.

Eligibility

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures & availability for study duration
Biologically female, aged ≥13, body weight ≥40kg

Inclusion criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures & availability for study duration
Biologically female, aged ≥13, body weight ≥40kg
Diagnosed with preeclampsia between 23-29+6/7 weeks gestation, by following criteria:
Blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic OR
Blood pressure ≥140 mmHg systolic or ≥90 mmHg diastolic and at least one of the following
i. Proteinuria (spot protein/creatinine ≥0.3mg/mg or 24Hr protein ≥300 mg) ii. Platelet count <100,000/μl iii. Aspartate or alanine transaminase >2x upper limit of normal iv. Creatinine >1.1 mg/dl or oliguria v. Pulmonary edema
Ability to take intravenous medication and be willing to adhere to the eculizumab regimen
Ability to receive meningococcal vaccine and be willing to adhere to antibiotic regimen

Exclusion Criteria:

An individual who meets any of the following criteria prior to enrollment will be excluded from participation in this study:
Known allergic reactions eculizumab or meningococcal vaccine
Febrile illness within prior 2 weeks
Treatment with another investigational drug within previous 6 months
Inpatient expectant management for preeclampsia >72 hours prior to enrollment
Fetal contraindication to expectant management of pregnancy
Platelet count <50,000/μl
Diagnosis of hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
Must meet all of the following criteria to be excluded: LDH >600 U/L, platelet count < 100,000/μl, AST >2x upper limit of normal, ALT >2x upper limit of normal
Diagnosis of Eclampsia
Diagnosis of Placental abruption
Intrauterine fetal demise
Coagulopathy (INR ≥ 1.5)
Fibrinogen <200 mg/dl
Persistent, severe headache unresponsive to medications
Persistent, severe visual disturbances
Persistent, severe epigastric or RUQ pain unresponsive to medications
Diagnosis of Systemic lupus erythematosus
Diagnosis of Anti-phospholipid antibody syndrome
Diagnosis of Atypical hemolytic uremic syndrome
Diagnosis of Paroxysmal nocturnal hemoglobinuria
Known complement deficiency
Diagnosis of Venous thromboembolism active or within 6 months of enrollment
Diagnosis of Human immunodeficiency virus (HIV)
Diagnosis of Hepatitis C virus (active viremia)
Diagnosis of Cancer (not in remission)
History of Solid organ transplant
Systemic viral or bacterial infection (active, untreated)
Active use of eculizumab at time of enrollment
Contraindication to eculizumab treatment or complement system blockade
Contraindication to meningococcal vaccine
Body weight <40kg
Age <13
Neutropenia (<1500/mm3)
Gonorrhea, chlamydia, or syphilis in current pregnancy
Illicit substance use in current pregnancy
Currently homeless or incarcerated
Alcoholism
Liver cirrhosis
Insulin dependent diabetes
Active use of immunosuppressive therapies, other than use of corticosteroids for fetal lung maturity
Use of prophylactic or therapeutic heparin, or low molecular weight heparin, in pregnancy for hypercoagulable condition

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study

Study Details

Disease Type/Condition

Other

Principal Investigator

Burwick, Richard

Age Group

Adult

Phase

IRB Number

STUDY00000039

ClinicalTrials.gov ID

NCT04725812

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org