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.
- Idiopathic Thrombocytopenic Purpura (ITP)
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Throughout study
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Experimental: Avatrombopag
1 of 2
Placebo Comparator:Placebo
1 of 2
Active Control
Non-Treatment Group
72 Total Participants · 2 Treatment Groups
Primary Treatment: Experimental: Avatrombopag · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 1 - 17 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor