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CSL312 for Hereditary Angioedema
Study Summary
This trial will study the long-term safety and effectiveness of CSL312 given as a shot under the skin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • 64 Patients • NCT04656418Trial Design
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Who is running the clinical trial?
Media Library
- I have been diagnosed with another type of swelling condition besides HAE.You have not taken the study drug CSL312 for at least 1 month before joining the trial.I am 12 years old or older.I am pregnant, breastfeeding, or not willing to stop breastfeeding.I am fertile, sexually active, and not using or unwilling to use birth control during and 30 days after the study.I have had 3 or more HAE attacks in the last 3 months.I have used estrogen-based birth control or hormone therapy in the last 4 weeks.I haven't used certain medications for HAE prevention for at least 2 weeks.I haven't used monoclonal antibodies like Takhzyro® in the last 3 months.I have been diagnosed with hereditary angioedema.I have had at least 1 HAE attack per month recently.
- Group 1: CSL312
- 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.
- 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 many test subjects are being given lenalidomide in this clinical trial?
"This study is not enrolling patients at the moment. The listing for this clinical trial was first posted on 29 March 2021 and updated on 2 November 2022. There are presently 23 other studies actively enrolling participants with angioedemas, hereditary and 2 studies for CSL312 that are recruiting patients."
Are we still looking for more people to participate in this clinical trial?
"The most recent information on clinicaltrials.gov shows that this study is not presently enrolling patients. The trial was initially posted on 3/29/2021 and was most recently edited on 11/2/2022. However, there are 25 other trials that are actively recruiting patients."
At how many hospitals or research facilities is this study taking place?
"The trial sites for this clinical study are PennState Health Milton S. Hershey Medical Center in Hershey, Pennsylvania, Little Rock Allergy & Asthma Clinic in Little Rock, Arkansas, Bernstein Clinical Research Center, LLC in Cincinnati, Ohio, and 5 other medical facilities."
If CSL312 has been studied before, where can I find those papers?
"The first clinical trial for CSL312 was conducted in 2021 at Queen Mary Hospital, which is part of The University of Hong Kong. As of now, there have been a total of 5 completed clinical trials. Out of the 2 that are currently ongoing, a large number are based in Hershey, Pennsylvania."
Does this medical research break new ground?
"CSL312 has been under investigation since early 2021. The first clinical trial, which was sponsored by CSL Behring, took place that year. After the successful Phase 1 study with 171 patients, CSL312 was approved for Phase 3 clinical trials. Now, there are 2 ongoing studies involving CSL312 in 51 cities and 18 countries."
Has CSL312 undergone evaluation by the FDA?
"CSL312 is a Phase 3 trial drug, so it has received a 3 for safety. This is due to the presence of data supporting both efficacy and multiple rounds of safety data."
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