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Ravulizumab for Paroxysmal Nocturnal Hemoglobinuria
Study Summary
This trial compares the effectiveness of two drugs in treating a blood disorder called PNH.
- Paroxysmal Nocturnal Hemoglobinuria
Timeline
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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Who is running the clinical trial?
Frequently Asked Questions
Has the federal government given its blessing to Ravulizumab?
"Ravulizumab has been shown to be safe in multiple clinical trials, so it received a score of 3."
What are the unique aspects of this particular clinical trial?
"Currently, there are 25 ongoing Ravulizumab studies in 45 countries and 240 cities. The first clinical trial for the drug was conducted by Alexion Pharmaceuticals in 2016 with 270 participants. As of now, 47 trials have been completed and Phase 3 approval has been granted."
What are the planned benefits of this clinical test?
"The primary outcome of this study, which will be measured over a Day 29 through Day 183 time frame is to Percentage Of Participants Who Achieved Transfusion Avoidance (TA). Secondary outcomes include Percentage Of Participants With Stabilized Hemoglobin Levels which is defined as Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline in the absence of transfusion through Day 183., Percentage Of Participants With Breakthrough Hemolysis (BTH) which is defined as Breakthrough hemolysis was defined as at least 1 new or worsening symptom or sign of intravascular hem"
In how many different geographical areas is this study being conducted?
"There are 4 primary enrolment centres for this study, situated in Los Angeles, Toronto, and Fort Worth. There are also other locations that participating patients can choose from to minimize travel requirements."
How many study participants are involved in this clinical trial?
"This trial is not actively searching for patients at this time. The study was first posted on December 20th, 2016 and was most recently edited on July 14th, 2022. If you are seeking other studies, there are currently 33 clinical trials actively recruiting patients with hemoglobinuria paroxysmal and 25 trials for Ravulizumab actively enrolling patients."
What are the primary indications for ravulizumab?
"Ravulizumab can be used as a treatment for patients who are complement inhibitor naive, have myasthenia gravis or generalized disease, or neuromyelitis optica."
Can new participants still join this clinical trial?
"The clinical trial mentioned is not currently looking for patients, as per the information available on clinicaltrials.gov. This particular trial was originally posted on December 20th 2016 and was edited most recently on July 14th 2022. There are 58 other trials which are actively recruiting patients."
Could you please share what other research studies have been done on Ravulizumab?
"Ravulizumab was first studied in 2016 and, since then, 47 trials have completed. Currently, 25 clinical trials are recruiting patients with a notable number of these taking place in Los Angeles and Texas."
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