PreeclampsiaPhase 2NCT06333652
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
A Phase 2 study testing Ravulizumab in people with Preeclampsia, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with < 34 0/7 weeks of gestation.
- Individuals with severe preeclampsia or HELLP features.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gonzalez Suarez contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Maria L. Gonzalez Suarez, MD,PhD, 5072844083, gonzalezsuarez.maria@mayo.edu
About this study
Official title: Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.
- Conditions
- Preeclampsia
- Being tested
- Ravulizumab
- Keywords
- Hemolysis, Elevated Liver enzymes, Low Platelets
- Medical subject headings
- Pre-Eclampsia, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Also called Ultomiris
Intravenous infusion 100 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Revulizumab Treatment | Experimental | Subjects will receive an single-dose infusion of Ravulizumab. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alternative Complement Pathway Biomarkers at time of delivery
Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery
Measured: Baseline
Secondary outcomes (4)
Pregnancy duration
Length of pregnancy measured in number of weeks.
Measured: 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
Measured: 72 hours after Ravulizumab infusion
Hospitalization length in the postpartum period
Length of hospital stay measured in number of days in hospital stay (peripartum period)
Measured: Approximately 3-5 days, it may vary
Meningococcal infection after use of ravulizumab
Number of participants to present a meningococcal infection after use of Ravulizumab
Measured: 72 hours up to 3 weeks after Ravulizumab infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Lourdes Gonzalez Suarez, Mayo Clinic
- Investigators
- Maria Lourdes Gonzalez Suarez, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333652
- Sponsor's protocol ID
- 22-009239
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No