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Monoclonal Antibodies

Ravulizumab for Thrombotic Microangiopathy

Phase 3
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights

Study Summary

This trial will study whether ravulizumab is effective and safe in adults with TMA associated with a trigger. Participants will be given either ravulizumab or placebo, and the treatment period is 26 weeks followed by a 26-week follow-up period.

Eligible Conditions
  • Thrombotic Microangiopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
Secondary outcome measures
Change From Baseline in eGFR at Week 26
Number of Participants On Dialysis at Week 26
Number of Participants With Hematologic Response at Week 26
+2 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
8%
Vomiting
8%
Abdominal pain upper
8%
Dyspnoea
8%
Urinary tract infection
8%
Anaemia
7%
Constipation
6%
Chest pain
6%
Dysphagia
5%
Gastroenteritis
5%
Pruritus
5%
Myalgia
5%
Palpitations
5%
Influenza
3%
Haemolysis
2%
Lower respiratory tract infection
2%
Haemolytic anaemia
1%
Basal cell carcinoma
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Colitis
1%
Bone marrow failure
1%
Infection
1%
Pneumonia
1%
Post procedural infection
1%
Liver disorder
1%
Depression
1%
Epilepsy
1%
Respiratory failure
1%
Enteritis
1%
Pneumoperitoneum
1%
Toothache
1%
Bile duct stone
1%
Biliary colic
1%
Cholecystitis
1%
COVID-19
1%
Bacteraemia
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Pneumonia bacterial
1%
Postoperative wound infection
1%
Rhinovirus infection
1%
Septic shock
1%
Ankle fracture
1%
Ligament injury
1%
Transfusion reaction
1%
Cerebrospinal fluid retention
1%
Loss of consciousness
1%
Dupuytren's contracture
1%
Intervertebral disc degeneration
1%
Osteonecrosis
1%
Ureterolithiasis
1%
Urinary retention
1%
Major depression
1%
Suicide attempt
1%
Dermal cyst
1%
Invasive papillary breast carcinoma
1%
Aplastic anaemia
1%
Breakthrough haemolysis
1%
Tibia fracture
1%
Lower limb fracture
1%
Deep vein thrombosis
1%
Endometrial cancer
1%
Lung cancer metastatic
1%
Renal cancer metastatic
1%
Seborrhoeic keratosis
1%
Pharyngitis
1%
Pneumococcal infection
1%
Liver function test increased
1%
Road traffic accident
1%
Suspected COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Eculizumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RavulizumabExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
39,264 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
254 Previous Clinical Trials
41,224 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,410 Total Patients Enrolled

Frequently Asked Questions

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

How many test subjects are a part of this clinical research?

"Unfortunately, this trial is no longer recruiting patients. The listing was active from July 1st 2021 to October 18th 2022. However, there are 118 other studies and 16 trials that might be of interest and are presently admitting patients."

Answered by AI

For what purpose is Ravulizumab most commonly prescribed?

"Not only can ravulizumab be used to lower disease activity, but it is also approved for the treatment of hemolysis, thrombotic microangiopathies, and atypical hemolytic uremic syndrome."

Answered by AI

What are the possible side effects of Ravulizumab?

"There is some evidence, from Phase 3 trials, to support both the efficacy and safety of Ravulizumab."

Answered by AI

Are there any available openings for new participants in this research?

"The trial described is not currently recruiting patients, as per the information available on clinicaltrials.gov. This particular study was posted on July 1st, 2021 and updated October 18th, 2022. There are other 134 ongoing trials that are actively looking for participants."

Answered by AI

In how many different medical clinics is this research study being conducted today?

"Currently, there are 16 active clinical trial sites for this medication. They are situated in cities such as Salt Lake City, Orange and Philadelphia; however, there may be a location near you too. If so, it would minimize travel to choose a local site."

Answered by AI

Is this an innovative or experimental study?

"Research into ravulizumab began in 2016 with the completion of the first clinical trial. Since then, there have been 16 active trials in 31 different countries."

Answered by AI

What is the efficacy of Ravulizumab in other populations?

"Ravulizumab's efficacy was first explored in 2016 through clinical trials. So far, there have been 18308 completed studies and 16 more are currently underway; many of these active sites are located in Salt Lake City, California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
2021. "Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04743804.
~4 spots leftby May 2025
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