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ALXN2050 for Paroxysmal Nocturnal Hemoglobinuria
Study Summary
This trial will test the efficacy and safety of the oral Factor D inhibitor ALXN2050 in patients with PNH who are treatment naïve or currently treated with eculizumab or ALXN2040.
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.Trial Design
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Who is running the clinical trial?
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- You have a specific type of blood cell clone that is larger than 10%.I am 18 years old or older.Your LDH levels in the blood are higher than 1.5 times the normal limit.I have a bleeding disorder or condition causing anemia not related to PNH.I have had a major organ or bone marrow transplant.I have a bone marrow condition needing a stem cell transplant or have been on immunosuppressants for less than 6 months.I have been treated with a complement inhibitor before.Your blood has low levels of hemoglobin (Hgb <10.5 g/dL).Your absolute reticulocyte count is 100 billion per liter or more.My kidney function is very low or I am on dialysis.You need to have at least 30,000 platelets in a small drop of your blood.You have taken danicopan during Study ACH471-103 in Group 3.Your body has enough infection-fighting white blood cells.I have been on a stable eculizumab dose for at least 24 weeks.I have been diagnosed with PNH.
- Group 1: Open-label ALXN2050 Monotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there still time to enroll in this experiment?
"This clinical trial is currently seeking participants. The necessary information was first made available on December 16th 2019, and the most recent update occurred October 20th 2022."
What is the aggregate figure of individuals participating in this clinical research?
"Affirmative. Evidence on clinicaltrials.gov indicates that this research project, which was initially posted on December 16th 2019, is actively recruiting participants. 26 individuals must be recruited from 2 different medical centres."
What is the regulatory status of ALXN2050?
"The safety of ALXN2050 has been assigned a score of 2, since there is evidence supporting its safety profile but no data confirming efficacy."
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