Status:
TERMINATED
Complement Regulation to Undo Systemic Harm in Preeclampsia
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Preeclampsia
Severe Preeclampsia
Eligibility:
FEMALE
13+ years
Phase:
PHASE2
Brief Summary
This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation.
Detailed Description
The purpose of this study is to determine if eculizumab is an effective treatment to prolong pregnancy in women with preeclampsia, compared to a historical control group of women that received standar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04725812
Start Date
September 13 2021
End Date
December 7 2021
Last Update
November 29 2023
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048