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Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria
Study Summary
This trial will test the safety and effectiveness of pegcetacoplan in adolescents with PNH.
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 2020 Phase 3 trial • 80 Patients • NCT03500549Trial Design
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Who is running the clinical trial?
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- I weigh at least 44 pounds.I have not used eculizumab or ravulizumab, or if I have, I still have anemia.I have been diagnosed with PNH through a specific blood test.I am not pregnant or breastfeeding.Your platelet and white blood cell counts are within a certain range.I have a history of complement deficiency, bone marrow transplant, or meningococcal disease.I am between 12 and 17 years old.I am 18 or older with PNH.I have or might have hereditary fructose intolerance.
- Group 1: Pegcetacoplan
- 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
Are there other ongoing or completed studies using Pegcetacoplan?
"11 different clinical trials are underway to research the efficacy of Pegcetacoplan. Of these, 5 are in Phase 3. The locations for these trials span from California to London, with a total of 593 sites running studies."
Does this research stand alone or has it been done before?
"As of right now, there are 11 ongoing Pegcetacoplan studies in 164 different cities and 26 countries. The first clinical trial for this medication was back in 2018 and it completed Phase 2 drug approval that year. Since then, 8 more trials have been conducted."
Has the FDA cleared Pegcetacoplan for use?
"Pegcetacoplan has received a 2 for safety. This is due to the lack of efficacy data, as this is only a Phase 2 trial."
How many volunteers are enrolling in this clinical trial?
"The answer is affirmative. According to the information available on clinicaltrials.gov, this particular clinical trial is still recruiting participants. The trial was originally posted on February 4th, 2021 and was updated for the last time on July 18th, 2022. They are looking for a total of 12 participants from 1 site."
Are people still being considered for participation in this trial?
"Yes, you're right. The website says that the trial is still looking for patients. They began recruiting on February 4th 2021 and the listing was updated last on July 18th, 2022. So far, 1 site has enrolled 12 people but they need more participants."
Does this trial have an age limit?
"This study is enrolling adolescent patients who are between 12 and 17 years old."
Could I potentially qualify to participate in this research?
"The inclusion criteria for this clinical trial requires that patients have hemoglobinuria, paroxysmal and are between the ages of 12-17. The study is looking to enroll a total of 12 participants."
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