Experimental: Avatrombopag for Thrombocytopenic Purpura

Dova Site, Long Beach, CA
Thrombocytopenic PurpuraAvatrombopag - Drug
1 - 17
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Idiopathic Thrombocytopenic Purpura (ITP)

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Throughout study

12 weeks
Platelet percentage
Rescue medications
12 weeks of treatment
Platelet Counts
Day 8
Platelet response
Week 12
Durable platelet response
Throughout study
Bleeding Symptoms

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Experimental: Avatrombopag
ActiveComparator Group · 1 Intervention: Avatrombopag · Intervention Types: Drug
Placebo Comparator:Placebo
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout study

Who is running the clinical trial?

Dova PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
276 Total Patients Enrolled
Sobi, Inc.Lead Sponsor
10 Previous Clinical Trials
534 Total Patients Enrolled

Eligibility Criteria

Age 1 - 17 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a boy or girl between the ages of 1 and 18 who has been diagnosed with primary ITP for at least 6 months and previous treatments have not worked according to the doctor.

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.