Ravulizumab in Pregnancies Complicated by Severe Hyperten... | NCT06333652

Studies
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

NCT06333652

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

14Estimated

Phase

Phase 2

Conditions

Preeclampsia

Interventions

Ravulizumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Mar 20, 2024

First Submission Date that Met QC Criteria

Mar 20, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Revulizumab Treatment	Experimental	Subjects will receive an single-dose infusion of Ravulizumab.	Drug: Ravulizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ravulizumab	Drug	Intravenous infusion 100 mg/ml	Revulizumab Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alternative Complement Pathway Biomarkers at time of delivery	Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy duration	Length of pregnancy measured in number of weeks.	Approximately 40 weeks
Clinical biomarkers of severe features of preeclampsia and HELLP syndrome	Concentration of clinical biomarkers in serum: creatinine, AST, ALT, LDH and platelets

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gonzalez Suarez	Contact	507-284-2511

Overall Officials

Name	Affiliation	Role
Maria Lourdes Gonzalez Suarez, MD, PhD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Minnesota	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D006461	Hemolysis

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000629409	ravulizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided