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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ last 8 weeks of 12 week treatment regimen
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last 8 weeks of 12 week treatment regimen
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 moreTrial 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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Avatrombopag
- Group 2: Placebo Comparator:Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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