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Ravulizumab for Thrombotic Microangiopathy
Study Summary
This trial will study the safety and effectiveness of a new drug, ravulizumab, in children who have undergone a stem cell transplant for a rare blood disorder. The treatment period is 26 weeks, followed by a 26-week follow-up period.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 195 Patients • NCT03056040Trial Design
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- I am under 18 years old.I will use effective birth control from screening until 8 months after my last dose.I have a deficiency in ADAMTS13 (less than 5% activity).I might have a condition that causes abnormal blood clotting throughout my body.I have been diagnosed with veno-occlusive disease.I am HIV positive.I have been diagnosed with a condition related to Shiga toxin affecting my kidneys.I currently have an untreated meningococcal infection.I have sepsis and need medication to maintain my blood pressure.My bone marrow is not functioning properly.I have been treated with a complement inhibitor before.My TMA condition continues despite initial treatments.I am vaccinated against meningococcal infections as recommended after my stem cell transplant.My body weight is at least 5 kilograms.I will receive antibiotics to prevent infection after my transplant, as per my hospital's guidelines.I had a stem cell transplant within the last 6 months.I must get re-vaccinated for Haemophilus influenzae type b and Streptococcus pneumoniae if possible.I cannot receive the meningococcal vaccine and will take antibiotics as protection during and 8 months after my treatment.
- Group 1: Ravulizumab plus Best Supportive Care
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this test still looking for volunteers?
"Although this thrombotic microangiopathies clinical trial was posted on 11/6/2020, it is not currently enrolling patients. The most recent edit to the study was on 8/1/2022. However, there are 117 other clinical trials currently looking for participants with thrombotic microangiopathies and 16 studies for Ravulizumab admitting patients."
What indications does Ravulizumab usually treat?
"Ravulizumab can be used to target disease activity, hemolysis, and thrombotic microangiopathies."
Are there any severe risks associated with Ravulizumab?
"There is pre-existing clinical data to support the safety of ravulizumab, giving it a score of 3."
What is the existing research on Ravulizumab?
"Ravulizumab was first studied in 2016. So far, there have been 28 completed trials and 16 active clinical trials. Many of the active trials are being conducted in Tucson, Arizona."
Across how many different locations is this clinical trial being managed?
"At the moment, there are 18 hospitals conducting this study. The list of sites includes locations such as Tucson, Aurora, Cleveland and 15 additional hospitals. If you choose to participate in this study, try to select a location nearest to you to cut down on travel."
Does this research project allow for elderly individuals above the age of seventy to participate?
"The age range for patients that can enroll in this clinical trial is 28 days old to 17 years old. Out of the 11 clinical trials available for minors, this is one of them. If a patient is 65 years or older, there are 122 trials they could potentially enroll in."
How many people are sign ups for this experiment?
"This study is no longer recruiting patients for participation. The trial was initial posted on November 6th, 2020 and was most recently updated on August 1st, 2022. However, there are presently 117 clinical trials actively enrolling patients with thrombotic microangiopathies and 16 studies for Ravulizumab actively enrolling patients."
Has this clinical trial been done before?
"Ravulizumab has been under investigation since 2016 when the first study, which was funded by Alexion Pharmaceuticals, concluded. After the 2016 study comprising of 270 people, Ravulizumab received Phase 3 drug approval. Presently, there are 16 active studies involving Ravulizumab across 31 countries and 193 cities."
Who meets the qualifications to take part in this clinical trial?
"This study is looking for 40 individuals that have thrombotic microangiopathies and meet the following requirements: they must be between 28 days and 17 years old, they must have received a HSCT within the past 12 months, their TMA diagnosis must persist for at least 72 hours despite initial management, and they must have a TMA diagnosis based on meeting the select criteria during the Screening Period and/or <=14 days prior to the Screening Period. Additionally, participants must weigh ≥ 5 kilograms, be vaccinated against meningococcal infections if clinically feasible, and use highly effective contraception if they are of child"
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