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Monoclonal Antibodies

Ravulizumab for Atypical Hemolytic Uremic Syndrome

Q: What other studies have there been with Ravulizumab?

Ravulizumab was first studied in 2016 and there have been 5 completed trials since then. Right now, 16 more are underway with a majority of them taking place in Atlanta, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.

Q: Does this clinical trial offer any treatments that have never been tried before?

Alexion Pharmaceuticals first sponsored a study on ravulizumab in 2016. After the successful Phase 1 and 2 trials, Ravulizumab received drug approval in 2016. As of now, there are 16 different ongoing studies involving 193 cities and 31 countries.

Q: Has Ravulizumab been cleared by the FDA?

There is both efficacy and safety data available for Ravulizumab thanks to it being a Phase 3 trial, thus our team has given it a score of 3.

Q: Are we still enrolling candidates for this trial?

This particular clinical trial, as evidenced by the data on clinicaltrials.gov, is not currently looking for new patients to enroll. Although this study is inactive at the moment, there are 1489 other medical trials that might be a better fit for people interested in participating in research.

Q: Could you give me a ballpark number of individuals who have signed up for this clinical trial?

Right now, this trial isn't looking for any new participants. The clinical trial was first posted on 8/31/2017 and the most recent edit was done on 7/1/2022. If you're interested in other studies, there are 1473 trials seeking patients with azotemia and 16 recruiting people for Ravulizumab.

Q: What are the primary conditions that Ravulizumab has been known to help with?

While disease activity is most commonly treated with Ravulizumab, this medication can also be used to help patients manage hemolysis, thrombotic microangiopathies, and atypical hemolytic uremic syndrome.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through at least week 52 and up to week 111

Awards & highlights

Study Summary

This trial will test the effectiveness of ravulizumab in controlling disease activity in children and adolescents with aHUS who have not previously used a complement inhibitor, as well as in those who have experience with eculizumab.

Eligible Conditions

Atypical Hemolytic Uremic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through at least week 52 and up to week 111

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through at least week 52 and up to week 111

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through at least week 52 and up to week 111 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Thrombotic Microangiopathies

Secondary outcome measures

Change From Baseline In Hemoglobin At Weeks 26 and 52

Change From Baseline In LDH At Weeks 26 and 52

Change From Baseline In Platelet Count At Weeks 26 and 52

+7 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

Hyperthermia

Cholelithiasis

Foot deformity

Basal cell carcinoma

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: RavulizumabExperimental Treatment1 Intervention

Participants were administered weight-based doses of ravulizumab every 8 weeks thereafter for participants weighing ≥ 20 kg, or once every 4 weeks for participant weighing < 20 kg, for a total of 26 weeks of study treatment in the initial Evaluation Period. After the Initial Evaluation Period, participants rolled over into an Extension Period in which all participant continued their weight-based maintenance dose until the product was registered or approved (in accordance with country specific regulation) or for up to 4.5 years, whichever occurred first.

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?

AlexionLead Sponsor

246 Previous Clinical Trials

39,233 Total Patients Enrolled

15 Trials studying Atypical Hemolytic Uremic Syndrome

3,431 Patients Enrolled for Atypical Hemolytic Uremic Syndrome

Alexion Pharmaceuticals, Inc.Lead Sponsor

252 Previous Clinical Trials

41,108 Total Patients Enrolled

16 Trials studying Atypical Hemolytic Uremic Syndrome

3,731 Patients Enrolled for Atypical Hemolytic Uremic Syndrome

Alexion PharmaceuticalsLead Sponsor

230 Previous Clinical Trials

37,379 Total Patients Enrolled

14 Trials studying Atypical Hemolytic Uremic Syndrome

3,406 Patients Enrolled for Atypical Hemolytic Uremic Syndrome

Frequently Asked Questions

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

What other studies have there been with Ravulizumab?

"Ravulizumab was first studied in 2016 and there have been 5 completed trials since then. Right now, 16 more are underway with a majority of them taking place in Atlanta, Georgia."

Answered by AI

Does this clinical trial offer any treatments that have never been tried before?

"Alexion Pharmaceuticals first sponsored a study on ravulizumab in 2016. After the successful Phase 1 and 2 trials, Ravulizumab received drug approval in 2016. As of now, there are 16 different ongoing studies involving 193 cities and 31 countries."

Answered by AI

Has Ravulizumab been cleared by the FDA?

"There is both efficacy and safety data available for Ravulizumab thanks to it being a Phase 3 trial, thus our team has given it a score of 3."

Answered by AI

Are we still enrolling candidates for this trial?

"This particular clinical trial, as evidenced by the data on clinicaltrials.gov, is not currently looking for new patients to enroll. Although this study is inactive at the moment, there are 1489 other medical trials that might be a better fit for people interested in participating in research."

Answered by AI

Could you give me a ballpark number of individuals who have signed up for this clinical trial?

"Right now, this trial isn't looking for any new participants. The clinical trial was first posted on 8/31/2017 and the most recent edit was done on 7/1/2022. If you're interested in other studies, there are 1473 trials seeking patients with azotemia and 16 recruiting people for Ravulizumab."

Answered by AI

What are the primary conditions that Ravulizumab has been known to help with?

"While disease activity is most commonly treated with Ravulizumab, this medication can also be used to help patients manage hemolysis, thrombotic microangiopathies, and atypical hemolytic uremic syndrome."

Answered by AI

Recent research and studies

Pediatric NephrologyJournal

The Long-acting C5 Inhibitor, Ravulizumab, Is Efficacious and Safe in Pediatric Patients with Atypical Hemolytic Uremic Syndrome Previously Treated with Eculizumab

Tanaka, Kazuki, Brigitte Adams, Alvaro Madrid Aris, Naoya Fujita, Masayo Ogawa, Stephan Ortiz, Marc Vallee, and Larry A. Greenbaum. 2020. “The Long-acting C5 Inhibitor, Ravulizumab, Is Efficacious and Safe in Pediatric Patients with Atypical Hemolytic Uremic Syndrome Previously Treated with Eculizumab”. Pediatric Nephrology. Springer Science and Business Media LLC. doi:10.1007/s00467-020-04774-2.

Kidney InternationalJournal

The Long-acting C5 Inhibitor, Ravulizumab, Is Effective and Safe in Adult Patients with Atypical Hemolytic Uremic Syndrome Naïve to Complement Inhibitor Treatment

Rondeau, Eric, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, et al.. 2020. “The Long-acting C5 Inhibitor, Ravulizumab, Is Effective and Safe in Adult Patients with Atypical Hemolytic Uremic Syndrome Naïve to Complement Inhibitor Treatment”. Kidney International. Elsevier BV. doi:10.1016/j.kint.2020.01.035.

clinicaltrials.govStudy

Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)

2017. "Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03131219.