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Crovalimab for Sickle Cell Disease (CROSSWALK-a Trial)
CROSSWALK-a Trial Summary
This trial is testing a new drug, crovalimab, to see if it is safe and effective for treating sickle cell pain crises in adults and adolescents.
CROSSWALK-a Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCROSSWALK-a Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CROSSWALK-a Trial Design
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Who is running the clinical trial?
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- I've had over 10 pain crises needing hospital visits in the last year.My liver and kidneys are working well.I have been on a stable dose of my sickle cell treatment for at least 28 days.I am hospitalized for a painful sickle cell crisis needing strong pain medication.My pain from the current episode has lasted more than 48 hours.I have had a stem cell transplant.I am vaccinated against H. influenzae type B and S. pneumoniae.I am vaccinated against meningitis ACWY.My pain does not match typical sickle cell crisis pain.I had a Neisseria meningitidis infection in the last 6 months.I weigh at least 40 kg.I might have a severe infection throughout my body.I have not had major surgery or been hospitalized in the last 30 days.I have been diagnosed with either sickle cell anemia or sickle cell beta zero thalassemia.I have been vaccinated against COVID-19 and it's been over 3 days since my last shot.I might have or am suspected to have acute coronary syndrome.I have a known or suspected genetic issue with my immune system.I have not had a blood transfusion or received blood products in the last 3 months.I have acute pain due to bone death, liver or spleen issues, or prolonged erection.I have not received a live vaccine in the last 30 days.I have not been in a drug study or taken experimental therapy in the last 28 days.
- Group 1: Crovalimab
- Group 2: Placebo
- 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
How widely is this trial being administered throughout the state?
"Participants in this trial are being recruited from Icahn School of Medicine at Mount Sinai (New york, NY), Children's Hospital of Michigan; Pediatrics (Detroit, MI), East Carolina University; Brody School of Medicine (Greenville, NC) and 4 other medical centres."
Has Crovalimab obtained authorization from the FDA?
"Crovalimab's safety is rated as a 1 on the scale because this clinical trial is in its early stages, meaning that there are limited data points to support both efficacy and protection from risks."
Are additional participants being sought out for this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial, which was initially posted on March 26th 2022 is currently recruiting patients for participation. A total of 30 individuals are being sought from 4 different sites."
Who has the qualifications to be considered a participant in this clinical trial?
"This clinical trial aims to enroll 30 individuals suffering from anemia and sickle cell, aged between 12 and 55. Applicants must have a confirmed diagnosis of HbSS or HbSβ0 (SCD genotype), as well as satisfactory renal/hepatic functions, hemoglobin over 5g/dL, platelet count greater than 100k µL, body weight at least 40 kgs. Furthermore, they should be vaccinated against Neisseria Meningitidis serotypes A-Y, SARS-CoV-2 (if administered more than 3 days prior) and Hib + Pneumococcal vaccines."
Is there a precedent of Crovalimab being used in previous research investigations?
"Crovalimab was initially studied in 2016 at Tokyo Medical University Hospital, and since then there have been 18327 separate clinical trials. Currently, 8 of these studies are active with a majority based out of New york City."
Does this trial represent a pioneering effort in its field?
"At the moment, Hoffmann-La Roche's Crovalimab has 8 active trials being conducted in 90 municipalities and 41 nations. This drug was first introduced for human testing back in 2016 with 59 subjects enrolled; since then, 18,327 studies have been completed up to Phase 1 & 2 approval status."
Could individuals younger than 35 years old partake in this trial?
"According to the age restrictions outlined in this medical trial, participants must be at least 12 years old and no older than 55."
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