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Pozelimab + Cemdisiran for Paroxysmal Nocturnal Hemoglobinuria (ACCESS-1 Trial)
ACCESS-1 Trial Summary
This trial will compare the effects of two different treatments for hemolysis (red blood cell breakdown) in patients with PNH. One treatment is a combination of two drugs, pozelimab and cemdisiran, and the other is ravulizumab. The trial will last 24 weeks, and the primary outcome measure is the effect on transfusions of RBCs. Secondary outcome measures include fatigue, quality of life, safety and tolerability, and complement activation.
ACCESS-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACCESS-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ACCESS-1 Trial Design
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Who is running the clinical trial?
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- I have symptoms related to PNH as described.I have not been vaccinated for meningococcal disease as required for my treatment.I cannot take antibiotics for meningococcal disease prevention as required.I do not have an active infection or haven't needed treatment for one in the last 2 weeks.Your LDH level is more than twice the normal limit at the screening visit.I haven't taken eculizumab, ravulizumab, or other complement inhibitors recently.My PNH diagnosis was confirmed by a specific blood test.I have had an organ or bone marrow transplant.I plan to only use the study drugs and no other complement inhibitor therapies during the treatment.I have an active autoimmune disease that is not under control.My body weight is less than 40 kilograms.
- Group 1: Cohort A
- Group 2: Cohort B
- 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
Does Pozelimab have a positive long-term effect on patients?
"Pozelimab has undergone multiple rounds of testing which have provided evidence for both its efficacy and safety, resulting in a score of 3."
What are the most recent findings on Pozelimab's efficacy?
"There are currently 21 clinical trials underway testing the efficacy of Pozelimab. Of those, 15 have reached Phase 3. The largest concentration of these studies is located in Bethesda, Maryland; however, there are 926 total research sites for this medication."
Are there currently any available positions for participants in this experiment?
"The information on clinicaltrials.gov confirms that this study is looking for patients at the moment. This trial was posted on 7/31/2022 and last updated on 5/3/2022. They are hoping to find 124 people total from 2 different locations."
What are the most frequent treatments that Pozelimab is used for?
"Pozelimab is most commonly used for those who have not previously tried a complement inhibitor. It can also be used to fight conditions such as hemolysis, thrombotic microangiopathies, and paroxysmal nocturnal haemoglobinuria (pnh)."
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