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Thrombopoietin Receptor Agonist

Avatrombopag for Low Platelet Count

Phase 4
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through day 90 or end of study
Awards & highlights

Study Summary

This trial is testing whether a drug called avatrombopag is safe and tolerated when given to people who have stopped taking eltrombopag or romiplostim.

Who is the study for?
This trial is for adults with chronic ITP who have been treated with eltrombopag or romiplostim for at least 90 days and had a positive response. Participants must be able to follow the study protocol and fill out a medication satisfaction questionnaire. Those currently on cancer treatments, previously used avatrombopag, or in another drug study recently cannot join.Check my eligibility
What is being tested?
The trial tests the safety of switching to Avatrombopag from Eltrombopag or Romiplostim over a period of 90 days in individuals with low platelet counts due to chronic ITP. It aims to assess how well patients tolerate Avatrombopag and their satisfaction with treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with drugs like Avatrombopag may include headache, fatigue, nausea, bruising or bleeding more easily than normal due to low platelet counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through day 90 or end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through day 90 or end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability (adverse events)
Secondary outcome measures
Platelet counts
Subject reported outcomes

Trial Design

1Treatment groups
Experimental Treatment
Group I: AvatrombopagExperimental Treatment1 Intervention
Avatrombopag 20 mg oral tablet formulation for 90 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avatrombopag Oral Tablet
2021
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

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

Media Library

Avatrombopag Oral Tablet (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04638829 — Phase 4
Thrombocytopenic Purpura Research Study Groups: Avatrombopag
Thrombocytopenic Purpura Clinical Trial 2023: Avatrombopag Oral Tablet Highlights & Side Effects. Trial Name: NCT04638829 — Phase 4
Avatrombopag Oral Tablet (Thrombopoietin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04638829 — Phase 4

Frequently Asked Questions

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

Have any additional investigations been conducted regarding this treatment regimen?

"The initial research on this treatment was conducted at Dova Site in 2018, and since then there have been 19 similar trials that have concluded. Currently, 11 studies are actively recruiting participants with a majority of them based out of New Orleans, Louisiana."

Answered by AI

Are there any openings remaining in this clinical research program?

"Going by the information on clinicaltrials.gov, this trial is currently in search of test subjects. It was originally published on March 15th 2021 and subsequently modified last November 1st 2022."

Answered by AI

How many individuals are engaged in this research study?

"To complete this study, 100 volunteers fitting the established criteria must be recruited. These patients can register for participation at Sobi Site 124 in New Orleans and additionally at Sobi Site 125 in Saint Petersburg, Florida."

Answered by AI

To what degree is this treatment hazardous for individuals?

"This medication has been approved for use and thus is given a score of 3 on the safety scale. This implies that phase 4 trials were conducted to confirm its efficacy and safety."

Answered by AI

Is this trial a pioneering endeavor?

"Presently, 11 trials for this pharmaceutical are taking place in 78 cities and 11 countries. The initial study was conducted by Sobi Incorporated in 2018 with a population of 122 volunteers which successfully completed the Phase 3 clinical trial phase. 19 additional studies have been finalized since then."

Answered by AI

How many venues are presently offering this research initiative?

"There are 36 centres offering this research opportunity, including Sobi Site 124 in New Orleans, Sobi Site 125 in Saint Petersburg and Sobi Site 126 in Peoria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
2021. "Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04638829.
~15 spots leftby Apr 2025
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