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Complement Regulation to Undo Systemic Harm in Preeclampsia

NCT04725812 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-11-29

Study results available
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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.

Conditions

  • Preeclampsia
  • Severe Preeclampsia
  • Eculizumab
  • HELLP
  • HELLP Syndrome
  • HELLP Syndrome Second Trimester
  • Pregnancy Related
  • AHUS
  • PNH
  • Complement Regulatory Factor Defect
  • Complement Abnormality
  • HELLP Syndrome Third Trimester

Interventions

DRUG

Eculizumab

Eculizumab Intravenous Solution

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Richard Burwick, MD, MPH · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2021-12-07
Completion
2021-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725812 on ClinicalTrials.gov