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Avatrombopag for Pediatric ITP
Study Summary
This trial is testing a new drug to treat thrombocytopenia (low platelet count) in children with Immune Thrombocytopenia (ITP) for at least 6 months.
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?
Media Library
- I have never had a blood clot in my arteries or veins.I do not have a history of heart defects or irregular heartbeats.I have never been diagnosed with myelodysplastic syndrome.Your blood platelet counts have been consistently low during the screening period.I am under 18, have had ITP for over 6 months, and treatments haven't worked well.I do not have a genetic condition that causes low platelet counts.I do not have a history of secondary immune thrombocytopenia.
- Group 1: Experimental: Avatrombopag
- Group 2: Placebo Comparator:Placebo
- 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
What is the Experimental: Avatrombopag's official standing with the FDA?
"There is some evidence backing the efficacy of avatrombopag as well as its safety, as this is a Phase 3 trial."
Will this be the first clinical trial of its kind?
"Avatrombopag has been under scientific scrutiny since 2018. After the first Phase 3 study, which was completed in 2018 and funded by Sobi, Inc., the drug was approved for public consumption. Currently, there are 9 ongoing studies involving Avatrombopag in 77 cities and 11 countries."
What are the entry requirements for this clinical trial?
"This medical trial is looking for 72 young patients, aged 1 to 17, who currently suffer from thrombocytopenia. In addition to meeting the age requirement, potential participants must also have had a primary ITP diagnosis for at least 6 months and must have shown an insufficient response to previous treatments. Platelet counts must average below 30×10^9/L, with no single count exceeding 35×10^9/L during the screening period."
Would this experiment be appropriate for elderly test subjects?
"The inclusion criteria for this trial requires that participants are children aged one year or older, but younger than 17."
Are there other research programs that have used Avatrombopag?
"Currently, there are nine clinical trials investigating the efficacy of avatrombopag. Three of those trials are in Phase 3. While many of the studies for avatrombopag are based in Tianjin, there are 214 locations running studies for this treatment."
Where are patients able to take part in this clinical trial?
"To date, 40 patients have enrolled in this trial at locations such as Dova in Orange, Site 107 in San Francisco, and Site 119 in Phoenix."
Are there opportunities available for people to enroll in this research project?
"From what is published on clinicaltrials.gov, it seems that this trial is still looking for volunteers. The posting went up on March 2nd, 2021 and the information was last updated on November 2nd, 2020."
How many patients are being given the opportunity to participate in this clinical trial?
"That is right, the online information does show that the research team is still looking for more participants. The original posting was on March 2nd, 2021 with the latest update being November 2nd, 2022. They need a total of 72 individuals across 40 different sites."
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