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New hope for low platelets: avatrombopag tested in japanese ITP patients

NCT ID NCT05369208

Disease control Sponsor: Sobi, Inc. Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called avatrombopag in 19 Japanese adults with chronic immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, raising bleeding risk. The goal was to see if the drug could safely increase platelet counts over 26 weeks. Participants had low platelet counts and had not responded well to prior treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

19 people

The number who actually took part.

Started

Jun 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has a confirmed diagnosis of chronic immune thrombocytopenia (ITP) (≥12 months duration) and has had an insufficient response to a previous ITP treatment, in the opinion of the Investigator. * Subject has an average of 2 platelet counts \<30×10\^9/L (no single count can be \>35×10\^9/L). The 2 samples must be obtained ≥48 hours and ≤2 weeks apart. Exclusion Criteria: * Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or subjects with known systemic lupus erythematosus). * Subjects with known inherited thrombocytopenia (e.g., Myosin Heavy Chain 9 (MYH-9) disorders) or hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency). * History of myelodysplastic syndrome (MDS). * History of arterial or venous thrombosis. * Subjects with a history of significant cardiovascular disease (e.g., congestive heart failure (CHF) New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events \[e.g., atrial fibrillation\], angina, coronary artery stent placement, angioplasty, coronary artery bypass grafting). * Subjects with a history of cirrhosis, portal hypertension, or chronic active hepatitis. * Subjects with concurrent malignant disease or receiving cytotoxic chemotherapy for a reason other than ITP treatment. * Use of immunoglobulins (IVIg and anti-D) or corticosteroid rescue therapy within 1 week of Day 1/Baseline. * Splenectomy or use of rituximab within 12 weeks of Day 1/Baseline. * Use of romiplostim or eltrombopag within 1 week of Day 1/Baseline. * Use of chronic corticosteroid treatment or azathioprine within 4 weeks of Day 1/Baseline, unless receiving a stable dose for at least 4 weeks. * Use of mycophenolate mofetil, cyclosporin A, or danazol within 4 weeks of Day 1/Baseline, unless receiving a stable dose for at least 12 weeks. * Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of Baseline Visit. * Currently receiving moderate or strong dual inhibitors/inducers of CYP2C9 and CYP3A4. * Serum creatinine ≥1.5× the upper limit of normal (ULN). * Serum bilirubin ≥2×ULN. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×ULN. * Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG) test) or breastfeeding. * Received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) before Day 1/Baseline.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune thrombocytopenia

Contacts and locations

Locations

  • Sobi Site 101

    Shiwa-gun, Iwata, 028-3695, Japan

  • Sobi Site 102

    Chuo-shi, Yamanashi, 409-3898, Japan

  • Sobi Site 103

    Bunkyō City, Toyko, 113-8603, Japan

  • Sobi Site 104

    Hachiōji-shi, Tokyo, 192-0032, Japan

  • Sobi Site 105

    Toyohashi, Aichi-ken, 441-8570, Japan

  • Sobi Site 106

    Suita, Osaka, 565-0871, Japan

  • Sobi Site 107

    Hirakata, Osaka, 573-1191, Japan

  • Sobi Site 108

    Kobe, Hyōgo, 650-0047, Japan

  • Sobi Site 109

    Hiroshima, Hiroshima, 730-0052, Japan

  • Sobi Site 110

    Tōon, Ehime, 791-0295, Japan

  • Sobi Site 111

    Fujisawa, Kanagawa, 251-8550, Japan

  • Sobi Site 112

    Kofu, Yamanashi, 400-8506, Japan

  • Sobi Site 113

    Kanazawa, Ishikawa-ken, 920-8650, Japan

  • Sobi Site 114

    Gifu, Gifu, 500-8513, Japan

  • Sobi Site 115

    Fukuyama-shi, Hiroshima, 720-2121, Japan

  • Sobi Site 116

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Sobi Site 117

    Kurume, Fukuoka, 830-8543, Japan

  • Sobi Site 118

    Iizuka-shi, Fukuoka, 820-8505, Japan

  • Sobi Site 119

    Kumamoto, Kumamoto, 862-8655, Japan

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