← Back to Search

Thrombopoietin Receptor Agonist

Avatrombopag for Pediatric ITP

Phase 3
Waitlist Available
Research Sponsored by Dova Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants ≥1 and <18 years of age at Screening and Baseline with a diagnosis of primary ITP for ≥6 months duration and has had an insufficient response to a previous treatment, in the opinion of the Investigator.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study
Awards & highlights

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.

Who is the study for?
This trial is for kids and teens (1-17 years old) with a condition called immune thrombocytopenia (ITP) that's lasted at least 6 months. They should have low platelet counts despite previous treatments but can't join if they've had blood clots, bone marrow disorders, certain heart issues, inherited platelet problems, or ITP caused by another disease.Check my eligibility
What is being tested?
The study tests Avatrombopag against a placebo to see if it's effective and safe in treating low platelet counts due to ITP in children. It's a phase 3b trial where participants are randomly chosen to receive either the actual drug or a dummy pill without any active ingredients.See study design
What are the potential side effects?
Avatrombopag may cause headaches, tiredness, stomach pain, nausea or vomiting. There might also be risks of liver problems and formation of blood clots. The exact side effects in children are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 18, have had ITP for over 6 months, and treatments haven't worked well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last 8 weeks of 12 week treatment regimen
This trial's timeline: 3 weeks for screening, Varies for treatment, and last 8 weeks of 12 week treatment regimen for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Durable platelet response
Secondary outcome measures
Bleeding Symptoms
Platelet Counts
Platelet percentage
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Experimental: AvatrombopagActive Control1 Intervention
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Group II: Placebo Comparator:PlaceboPlacebo Group1 Intervention
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks

Find a Location

Who is running the clinical trial?

Dova PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
236 Total Patients Enrolled
Sobi, Inc.Lead Sponsor
12 Previous Clinical Trials
552 Total Patients Enrolled

Media Library

Avatrombopag (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04516967 — Phase 3
Thrombocytopenic Purpura Research Study Groups: Experimental: Avatrombopag, Placebo Comparator:Placebo
Thrombocytopenic Purpura Clinical Trial 2023: Avatrombopag Highlights & Side Effects. Trial Name: NCT04516967 — Phase 3
Avatrombopag (Thrombopoietin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516967 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~19 spots leftby Mar 2025