Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
NCT ID: NCT04516967
Last Updated: 2026-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2021-03-05
2025-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental: Avatrombopag Double Blind
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Avatrombopag
Oral avatrombopag tablet or sprinkle capsule
Placebo Comparator:Placebo Double Blind
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Placebo
Placebo comparator tablet or sprinkle capsule
Avatrombopag Open Label Extension
Investigational product administered orally for up to 2 years.
Avatrombopag
Oral avatrombopag tablet or sprinkle capsule
Interventions
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Avatrombopag
Oral avatrombopag tablet or sprinkle capsule
Placebo
Placebo comparator tablet or sprinkle capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has an average of 2 platelet counts \<30×10\^9/L with no single count \>35×10\^9/L in the screening period
Exclusion Criteria
1 Year
17 Years
ALL
No
Sponsors
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Sobi, Inc.
INDUSTRY
Responsible Party
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Locations
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Site 112
Phoenix, Arizona, United States
Site 103
Long Beach, California, United States
Site 119
Orange, California, United States
Site 109
Sacramento, California, United States
Site 101
San Francisco, California, United States
Site 111
Aurora, Colorado, United States
Site 120
Wilmington, Delaware, United States
Site 117
Gainesville, Florida, United States
Site 116
Atlanta, Georgia, United States
Site 107
Peoria, Illinois, United States
Site 104
Boston, Massachusetts, United States
Site 105
Minneapolis, Minnesota, United States
Site 114
Jackson, Mississippi, United States
Site 102
Las Vegas, Nevada, United States
Site 108
Morristown, New Jersey, United States
Site 118
Charlotte, North Carolina, United States
Site 113
Durham, North Carolina, United States
Site 106
Columbus, Ohio, United States
Site 121
Philadelphia, Pennsylvania, United States
Site 110
Providence, Rhode Island, United States
Site 115
Houston, Texas, United States
Site 201
Toulouse, Occitanie, France
Site 202
Paris, Île-de-France Region, France
Site 301
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Site 303
Kiel, Schleswig-Holstein, Germany
Site 304
Berlin, , Germany
Site 302
Hamburg, , Germany
Site 801
Budapest, , Hungary
Site 802
Miskolc, , Hungary
Site 803
Pécs, , Hungary
Site 502
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Site 503
Warsaw, Masovian Voivodeship, Poland
Site 505
Zabrze, Silesian Voivodeship, Poland
Site 501
Olsztyn, Warmian-Masurian Voivodeship, Poland
Site 504
Lodz, Łódź Voivodeship, Poland
Site 907
Chelyabinsk, , Russia
Site 904
Moscow, , Russia
Site 906
Moscow, , Russia
Site 901
Moscow, , Russia
Site 902
Nizhny Novgorod, , Russia
Site 905
Saint Petersburg, , Russia
Site 903
Volgograd, , Russia
Site 701
Adana, , Turkey (Türkiye)
Site 704
Ankara, , Turkey (Türkiye)
Site 706
Antalya, , Turkey (Türkiye)
Site 702
Antalya, , Turkey (Türkiye)
Site 705
Denizli, , Turkey (Türkiye)
Site 709
Istanbul, , Turkey (Türkiye)
Site 710
Istanbul, , Turkey (Türkiye)
Site 703
Istanbul, , Turkey (Türkiye)
Site 707
Izmir, , Turkey (Türkiye)
Site 708
Mersin, , Turkey (Türkiye)
Site 954
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Site 952
Vinnytsia, , Ukraine
Site 405
Birmingham, England, United Kingdom
Site 408
Liverpool, England, United Kingdom
Site 403
London, England, United Kingdom
Site 410
London, England, United Kingdom
Site 407
London, England, United Kingdom
Site 402
Manchester, England, United Kingdom
Site 401
Sheffield, England, United Kingdom
Site 406
Cardiff, Wales, United Kingdom
Countries
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References
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Grace RF, Leblebisatan G, Aydinok Y, Unal S, Grainger JD, Zhang J, Smallwood L, de Leon E, Jamieson BD; AVA-PED-301 Study Group. Avatrombopag for the treatment of children and adolescents with immune thrombocytopenia (AVA-PED-301): a multicentre, randomised, double-blind, placebo-controlled, phase 3b study. Lancet Haematol. 2025 Jul;12(7):e494-e504. doi: 10.1016/S2352-3026(25)00107-3. Epub 2025 May 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVA-PED-301
Identifier Type: -
Identifier Source: org_study_id
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