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Monoclonal Antibodies
Crovalimab for Atypical Hemolytic Uremic Syndrome (COMMUTE-p Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body weight >= 5 kg at screening
Vaccination against Neisseria meningitis serotypes A, C, W, and Y; vaccination against serotype B, according to national vaccination recommendations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
COMMUTE-p Trial Summary
This trial will test if crovalimab is safe and effective in children with aHUS.
Who is the study for?
This trial is for children with atypical Hemolytic Uremic Syndrome (aHUS) who weigh at least 5 kg and are vaccinated against certain infections. They must not have HIV, active hepatitis B/C, or other conditions that could cause similar symptoms. Those with a kidney transplant due to aHUS can join; females of childbearing age should use contraception.Check my eligibility
What is being tested?
The study tests Crovalimab's effectiveness and safety in treating pediatric aHUS patients. It includes those new to treatment, switching from another C5 inhibitor therapy, or having specific genetic variations affecting their response to such treatments.See study design
What are the potential side effects?
While the side effects of Crovalimab aren't detailed here, it's common for drugs like this to potentially cause infusion reactions, increase infection risk, and possibly lead to abnormal blood test results reflecting organ function.
COMMUTE-p Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My body weight is at least 5 kg.
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I am vaccinated against meningitis as per my country's guidelines.
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My TMA is not well-managed after treatment with a C5 inhibitor.
COMMUTE-p Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change from Baseline in Dialysis Status
Change from Baseline in Hemoglobin (mg/dL) (Naive and Switch Cohorts)
Change from Baseline in Lactate Dehydrogenase (LDH) (mg/dL) (Naive and Switch Cohorts)
+19 moreCOMMUTE-p Trial Design
1Treatment groups
Experimental Treatment
Group I: CrovalimabExperimental Treatment1 Intervention
Participants will be enrolled in three cohorts: [1] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; [2] Switch Cohort - participants who switch to crovalimab from another C5 inhibitor and [3] Pretreated Cohort (includes C5 SNP (Single Nucleotide Polymorphism) participants) - participants who received treatment with another C5 inhibitor and subsequently discontinued it.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,377 Total Patients Enrolled
1 Trials studying Atypical Hemolytic Uremic Syndrome
80 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,659 Total Patients Enrolled
1 Trials studying Atypical Hemolytic Uremic Syndrome
80 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,687 Total Patients Enrolled
1 Trials studying Atypical Hemolytic Uremic Syndrome
80 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a fever of 38°C or higher in the last 7 days.My organs are failing.I have been on chronic dialysis or have end-stage kidney disease.I haven't been in a drug study or taken experimental therapy in the last 28 days.I have recently received IVIg treatment.I have had kidney disease, but not aHUS.You have tested positive for HIV.I have an active Hepatitis B or C infection.I have not had a serious infection in the last 14 days.I have a specific genetic variation related to my condition.I have started PE/PI treatment within the last 8 weeks.My body weight is at least 5 kg.I am vaccinated against meningitis as per my country's guidelines.I have recently used tranexamic acid.I have never been treated with a complement inhibitor.I am vaccinated against Haemophilus influenzae type B and Streptococcus pneumoniae as recommended.You developed a certain type of medical condition within 28 days before starting the crovalimab treatment.I have been treated with eculizumab or ravulizumab.My TMA is not well-managed after treatment with a C5 inhibitor.I have a condition caused by a reaction to a medication.I have had a meningitis infection in the last 6 months.I started plasma treatments no more than 28 days before my first crovalimab dose.I've been on a stable dose of my current medication for at least 28 days before starting crovalimab.I have shown improvement with a C5 inhibitor treatment.I have or had a condition like cancer, transplant, or autoimmune disease that could cause TMA.I have cryoglobulinemia and was recently treated with a C5 inhibitor.I had aHUS before my kidney transplant.I completed my last physical exam less than 2 hours before my first crovalimab dose.I often get infections, suggesting I might have a weak immune system.My TMA is not caused by aHUS but by another condition like TTP or E. coli.You have a positive direct Coombs test.My kidney disease is not caused by atypical HUS.
Research Study Groups:
This trial has the following groups:- Group 1: Crovalimab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a potential test subject is 35 years old or younger, do they qualify for this research project?
"This clinical trial is looking for patients that are under 17 years old and have been 28 days since their last birthday."
Answered by AI
Are there any patients that this study is still recruiting?
"This study, which can be found on clinicaltrials.gov, is actively recruiting participants. The trial was first posted on November 17, 2021 and was last updated on October 17, 2022."
Answered by AI
What are the most similar drugs to Crovalimab?
"There are 8 clinical trials ongoing that are researching Crovalimab with 5 trials being in Phase 3. Many of the clinical trials for Crovalimab are running out of in Sevilla, Kentucky, but there are 488 locations globally that are operating trials for Crovalimab."
Answered by AI
Does this clinical trial utilize any innovative methods?
"Since 2016, Crovalimab has been the focus of 8 clinical trials. The first occurred in 2016, and was sponsored by Hoffmann-La Roche. This initial study included 59 participants. Crovalimab received Phase 1 & 2 drug approval after the first trial. Currently, there are 8 live trials for Crovalimab taking place in 90 cities and 41 countries."
Answered by AI
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