Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
NCT ID: NCT04638829
Last Updated: 2025-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2021-03-15
2024-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avatrombopag
Avatrombopag 20 mg oral tablet formulation for 90 days
Avatrombopag Oral Tablet
Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information
Interventions
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Avatrombopag Oral Tablet
Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has had a previous response (at any time) to either eltrombopag or romiplostim, defined as at least 2 platelet counts ≥50×10⁹/L. Subject is willing and able to comply with all aspects of the protocol, including completing the self-administered Treatment Satisfaction Medication Questionnaire (TSQM).
Exclusion Criteria
* Subject with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate to severe dementia, and/or severe and progressive medical illness, as determined by the Investigator.
* Any previous avatrombopag use.
* Previous participation in this study; a subject may not re-enroll after prior discontinuation or completion.
* Enrollment in another clinical study with any investigational drug or device within 30 days of Baseline (or 5 half-lives, whichever is longer); however, participation in observational studies within the previous 30 days is permitted.
18 Years
ALL
No
Sponsors
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Sobi, Inc.
INDUSTRY
Responsible Party
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Locations
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Sobi Site 110
Tucson, Arizona, United States
Sobi Site 119
Whittier, California, United States
Sobi Site 123
Washington D.C., District of Columbia, United States
Sobi Site 129
Miami, Florida, United States
Sobi Site 120
Ocala, Florida, United States
Sobi Site 125
St. Petersburg, Florida, United States
Sobi Site 118
Tampa, Florida, United States
Sobi Site 126
Chicago, Illinois, United States
Sobi Site 109
Peoria, Illinois, United States
Sobi Site 124
New Orleans, Louisiana, United States
Sobi Site 101
Bethesda, Maryland, United States
Sobi Site 103
Lincoln, Nebraska, United States
Sobi Site 121
Chapel Hill, North Carolina, United States
Sobi Site 116
Greenville, North Carolina, United States
Sobi Site 128
Cleveland, Ohio, United States
Sobi Site 127
Philadelphia, Pennsylvania, United States
Sobi Site 102
York, Pennsylvania, United States
Sobi Site 104
Rock Hill, South Carolina, United States
Sobi Site 113
Dallas, Texas, United States
Sobi Site 108
Salt Lake City, Utah, United States
Countries
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References
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Tarantino MD, Mosalpuria K, Kolodny S, Zhang J, Vredenburg M, Jamieson BD. Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA. Blood Adv. 2025 Jun 10;9(11):2733-2743. doi: 10.1182/bloodadvances.2024015635.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVA-ITP-401
Identifier Type: -
Identifier Source: org_study_id
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