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Monoclonal Antibodies

Revulizumab Treatment for Prophylaxis of Preeclampsia

Phase 2

Recruiting

Led By Maria Lourdes Gonzalez Suarez, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours after ravulizumab infusion

Awards & highlights

Study Summary

"This trial is testing a medication called ravulizumab to see if it can help treat severe preeclampsia and a condition called HELLP syndrome."

Who is the study for?

This trial is for pregnant individuals with severe preeclampsia or HELLP syndrome, which involves high blood pressure and other complications. Specific eligibility details are not provided, but typically participants must meet certain health standards to ensure safety.Check my eligibility

What is being tested?

The study is examining the effectiveness of ravulizumab in treating severe preeclampsia and HELLP syndrome during pregnancy. The goal is to see if this medication can help manage these conditions.See study design

What are the potential side effects?

While specific side effects for ravulizumab in this trial context aren't listed, common ones may include headache, nausea, infections, and potential infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alternative Complement Pathway Biomarkers at time of delivery

Secondary outcome measures

Clinical biomarkers of severe features of preeclampsia and HELLP syndrome

Hospitalization length in the postpartum period

Meningococcal infection after use of ravulizumab

+1 more

Side effects data

From 2022 Phase 3 trial • 195 Patients • NCT03056040

31%

Headache

30%

Nasopharyngitis

28%

Upper respiratory tract infection

21%

Fatigue

19%

Diarrhoea

19%

Pyrexia

18%

Nausea

17%

Cough

15%

Abdominal pain

14%

Back pain

14%

Dizziness

13%

Pain in extremity

11%

Arthralgia

11%

Influenza like illness

10%

Oropharyngeal pain

10%

Rhinitis

Vomiting

Abdominal pain upper

Dyspnoea

Urinary tract infection

Anaemia

Constipation

Chest pain

Dysphagia

Gastroenteritis

Pruritus

Myalgia

Palpitations

Influenza

Haemolysis

Lower respiratory tract infection

Haemolytic anaemia

Basal cell carcinoma

Hyperthermia

Cholelithiasis

Foot deformity

Colitis

Bone marrow failure

Infection

Pneumonia

Post procedural infection

Liver disorder

Depression

Epilepsy

Respiratory failure

Enteritis

Pneumoperitoneum

Toothache

Bile duct stone

Biliary colic

Cholecystitis

COVID-19

Bacteraemia

Escherichia sepsis

Escherichia urinary tract infection

Pneumonia bacterial

Postoperative wound infection

Rhinovirus infection

Septic shock

Ankle fracture

Ligament injury

Transfusion reaction

Cerebrospinal fluid retention

Loss of consciousness

Dupuytren's contracture

Intervertebral disc degeneration

Osteonecrosis

Ureterolithiasis

Urinary retention

Major depression

Suicide attempt

Dermal cyst

Invasive papillary breast carcinoma

Aplastic anaemia

Breakthrough haemolysis

Tibia fracture

Lower limb fracture

Deep vein thrombosis

Endometrial cancer

Lung cancer metastatic

Renal cancer metastatic

Seborrhoeic keratosis

Pharyngitis

Pneumococcal infection

Liver function test increased

Road traffic accident

Suspected COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Ravulizumab

Eculizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Revulizumab TreatmentExperimental Treatment1 Intervention

Subjects will receive an single-dose infusion of Ravulizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ravulizumab

2021

Completed Phase 4

~1080

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,474 Total Patients Enrolled

Maria Lourdes Gonzalez Suarez, MD, PhDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential hazards associated with Revulizumab therapy for individuals?

"Our team at Power has rated the safety of Revulizumab Treatment as a 2 on a scale from 1 to 3. This evaluation is based on it being a Phase 2 trial, implying that there is existing data supporting its safety but none confirming its efficacy."

Answered by AI

Which individuals meet the criteria to participate in this research investigation?

"In order to be considered for participation in this research, individuals must have a preventive treatment plan for preeclampsia and fall within the age range of 18 to 50. Approximately 14 participants will be accepted into the study."

Answered by AI

Are potential participants currently able to apply for this ongoing medical study?

"According to details available on clinicaltrials.gov, this research project is currently in the process of seeking suitable participants. Initially uploaded on April 1st, 2024, the most recent revision was made on March 20th, 2024."

Answered by AI

What is the upper limit for the number of participants involved in this research endeavor?

"Indeed, information on clinicaltrials.gov confirms the ongoing patient recruitment for this trial. The study was first posted on April 1st, 2024 and last updated on March 20th, 2024. It aims to enroll a total of 14 participants from one site."

Answered by AI