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Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

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ClinicalTrials.gov Identifier: NCT06333652
Recruitment Status : Recruiting
First Posted : March 27, 2024
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Maria Lourdes Gonzalez Suarez, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE March 20, 2024
First Posted Date  ICMJE March 27, 2024
Last Update Posted Date April 22, 2024
Estimated Study Start Date  ICMJE June 1, 2024
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2024)		 Alternative Complement Pathway Biomarkers at time of delivery [ Time Frame: Baseline ]
Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2024)		 Biomarkers at time of delivery [ Time Frame: Baseline ]
Number of subjects to biomarkers sMAC, Bb, and C5 at time of delivery
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2024)
  • Pregnancy duration [ Time Frame: Approximately 40 weeks ]
    Length of pregnancy measured in number of weeks.
  • Clinical biomarkers of severe features of preeclampsia and HELLP syndrome [ Time Frame: 72 hours after Ravulizumab infusion ]
    Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets
  • Hospitalization length in the postpartum period [ Time Frame: Approximately 3-5 days, it may vary ]
    Length of hospital stay measured in number of days in hospital stay (peripartum period)
  • Meningococcal infection after use of ravulizumab [ Time Frame: 72 hours up to 3 weeks after Ravulizumab infusion ]
    Number of participants to present a meningococcal infection after use of Ravulizumab
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2024)
  • Pregnancy duration [ Time Frame: Approximately 40 weeks ]
    Duration of pregnancy measure in weeks
  • Clinical biomarkers of severe features of preeclampsia and HELLP syndrome [ Time Frame: 72 hours after Ravulizumab infusion ]
    Number of subjects to have clinical biomarkers in serum creatinine, AST level, ALT level, and LDH level
  • Platelets count [ Time Frame: 72 hours after Ravulizumab infusion ]
    Reported in platelets per microliter of blood
  • Hospital length of stay in the postpartum period [ Time Frame: Postpartum period approximately 3-5 days ]
    Number of days in hospital stay for postpartum period
  • Meningococcal infection after use of ravulizumab [ Time Frame: 72 hours after Ravulizumab infusion ]
    Number of subjects to have a meningococcal infection after use of ravulizumab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Official Title  ICMJE Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Brief Summary The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Preeclampsia
Intervention  ICMJE Drug: Ravulizumab
Intravenous infusion 100 mg/ml
Other Name: Ultomiris
Study Arms  ICMJE Experimental: Revulizumab Treatment
Subjects will receive an single-dose infusion of Ravulizumab.
Intervention: Drug: Ravulizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2024)		 14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2028
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals with < 34 0/7 weeks of gestation.
  • Individuals with severe preeclampsia or HELLP features.

Exclusion Criteria:

  • Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC).
  • Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06333652
Other Study ID Numbers  ICMJE 22-009239
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Maria Lourdes Gonzalez Suarez, Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Lourdes Gonzalez Suarez, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP