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Berotralstat for Pediatric Hereditary Angioedema (APeX-P Trial)
APeX-P Trial Summary
This trial is testing a new drug to see if it's safe and effective in treating hereditary angioedema in children.
APeX-P Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAPeX-P Trial Timeline
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 2 & 3 trial • 387 Patients • NCT03472040APeX-P Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with another type of recurring swelling attacks.A family member has died suddenly from heart issues.I am a boy or a girl not pregnant or breastfeeding, aged 2 to under 12.My body weight is at least 12 kg.Your liver enzyme levels are more than three times the normal range for your age.Your kidneys are not filtering waste from your blood well enough.My heart's electrical activity is normal, with no significant irregularities.I have been diagnosed with Hereditary Angioedema.
- Group 1: Berotralstat
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Has Berotralstat undergone the necessary drug testing to be cleared for public use?
"There is some evidence from previous clinical trials to support the efficacy of Berotralstat as well as data suggesting it is safe for use. Therefore, we have rated it a 3 on our Power scale."
How many people are being asked to participate in this experiment?
"That is correct. The clinical trial, which was posted on October 1st, 2020 and last updated on October 21st, 2020, is still recruiting patients. They are looking for a total of 20 people across 1 site."
Are investigators still signing up new participants for this research project?
"That is correct. The clinical trial, which is currently looking for 20 patients from 1 site, was posted on October 1st, 2020 and last updated 21 days ago on October 21st, 2020 according to the data available on clinicaltrials.gov"
Could I be a candidate for this research project?
"Up to 20 children aged 2-11 can participate in this study. To be eligible, they must meet the following requirements: Be male or non-pregnant/non-lactating female, weigh more than 12 kg, have a diagnosis of HAE from a doctor, and be someone that would benefit from long term prophylaxis according to the investigator's opinion."
Are people of all ages being considered for this clinical trial or are only young adults eligible?
"This clinical trial is only for patients aged 2-11. There are a total of 33 studies for children and 19 for seniors."
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