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Crovalimab for Sickle Cell Disease (CROSSWALK-c Trial)
CROSSWALK-c Trial Summary
This trial will compare the effectiveness of crovalimab versus placebo at preventing vascular occlusive events (VOEs) in people with sickle cell disease.
CROSSWALK-c Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCROSSWALK-c Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CROSSWALK-c Trial Design
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Who is running the clinical trial?
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- I have not had a serious infection in the last 14 days.I have been on a stable dose of erythropoietin for at least 3 months.I have been vaccinated against COVID-19 with an approved vaccine at least 3 days ago.I weigh at least 40 kg.I have been diagnosed with either sickle cell anemia or sickle cell beta zero thalassemia.My liver and kidneys are working well.I have had a fever of 38°C or higher in the past week.I am part of a chronic transfusion program or will have an exchange transfusion during the study.I am vaccinated against meningitis, Hib, and pneumonia.I have had a meningitis infection in the last 6 months.I have had a stem cell transplant.I've been on a stable dose of my current sickle cell disease treatment for at least 3 months.I have not received a live vaccine in the last month.I have HIV with a CD4 count below 200 in the last 24 weeks.I have a genetic issue affecting my immune system.
- 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
Does the age restriction for this medical experiment permit individuals under 35?
"The enrollment criteria for this trial requires participants to be between 12 and 55 years of age."
Are there any safety concerns related to Crovalimab utilization?
"Our team at Power has ranked the safety of Crovalimab as a 2, indicating that there is evidence pointing to its safety, but no data yet affirming its efficacy."
How many participants have enrolled in this trial thus far?
"Indeed, the information posted on clinicaltrials.gov confirms that this medical trial is presently recruiting participants. It was first listed on March 9th 2022 and has been recently updated as of November 8th 2022; it requires 90 individuals to be recruited from 5 different sites."
What prior experiments have involved Crovalimab?
"Crovalimab was initially researched in 2016 at Tokyo Medical University Hospital, with a total of 18321 completed studies. There are 8 currently active clinical trials being conducted, many of which take place out of Greenville, North carolina."
Are there any vacancies for participants in this experiment?
"Per the data published on clinicaltrials.gov, this ongoing medical investigation is still searching for trial participants. It was initially posted on March 9th 2022 and most recently updated in November 8th of the same year."
How unprecedented is this clinical experiment?
"Presently, 8 Crovalimab trials are running in 90 cities and 41 countries. Hoffmann-La Roche was the first to trial this drug back in 2016 with 59 participants; a Phase 1 & 2 approval stage followed suit immediately after. Since then, 18,321 studies have been completed concerning this medication."
Who is eligible to partake in this research trial?
"This clinical trial is actively seeking 90 individuals between the ages of 12 and 55, with a confirmed diagnosis of sickle cell anemia. Furthermore, these patients must not be undergoing any alterations to their medication dosage other than for safety reasons; have been vaccinated against N. meningitides serotypes A, C, W and Y as well as H. influenza type B and S. pneumonia.; demonstrate adequate hepatic and renal function; agree to abstain from or use contraception during treatment period 10 months after final dose; weigh 40 kg or more; have experienced two to ten documented vaso-occlusive episodes in the twelve months prior to"
How many sites are involved in the implementation of this trial?
"As of now, there are 5 sites that are currently enrolling patients. These locations include Greenville, Detroit, and New Hyde Park alongside other cities in the vicinity. If you do decide to join this trial it is recommended to choose the closest site so as to reduce travelling demands."
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