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Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP

Sponsor
Sobi, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05369208
Collaborator
(none)
19
Enrollment
19
Locations
1
Arm
42.5
Anticipated Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).

Condition or Disease Intervention/Treatment Phase
  • Drug: Avatrombopag Oral Tablet
 Phase 3

Detailed Description

This Phase 3, multicenter, open label study will evaluate the efficacy, safety, and population pharmacokinetics (PK) of avatrombopag in Japanese adults with chronic ITP. At least 19 subjects will be enrolled. The study will consist of 3 phases: Pre-enrollment, Primary Investigation, and Extension Phase until market authorization in Japan.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic Immune Thrombocytopenia
Actual Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Avatrombopag

Avatrombopag 20 mg oral tablet

Drug: Avatrombopag Oral Tablet
Avatrombopag 20 mg given once daily (initial dose). Dose adjustments will be determined by the physician and in accordance with the overseas Doptelet prescribing information.
Other Names:
  • Doptelet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative Number of Weeks of Platelet Response [26 weeks of active treatment]

      Cumulative number of weeks in which the platelet count is ≥50×10^9/L during 26 weeks of treatment in the absence of rescue therapy.

    Secondary Outcome Measures

    1. Response Rate at Day 8 [Day 8]

      Proportion of subjects with a platelet response ≥50×10^9/L at Day 8 in the absence of rescue therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sobi Site 105 Toyohashi Aichi Japan 441-8570
    2 Sobi Site 110 Toon City Ehime Japan 791-0295
    3 Sobi Site 118 Iizuka-shi Fukuoka Japan 820-8505
    4 Sobi Site 116 Kitakyushu City Fukuoka Japan 802-8555
    5 Sobi Site 117 Kurume City Fukuoka Japan 830-8543
    6 Sobi Site 114 Gifu City Gifu Japan 500-8513
    7 Sobi Site 115 Fukuyama-shi Hiroshima Japan 720-2121
    8 Sobi Site 109 Hiroshima City Hiroshima Japan 730-0052
    9 Sobi Site 108 Kobe Hyogo Japan 650-0047
    10 Sobi Site 113 Kanazawa Ishikawa Japan 920-8650
    11 Sobi Site 101 Shiwa-gun Iwata Japan 028-3695
    12 Sobi Site 111 Fujisawa City Kanagawa Japan 251-8550
    13 Sobi Site 119 Kumamoto-shi Kumamoto Japan 862-8655
    14 Sobi Site 107 Hirakata City Osaka Japan 573-1191
    15 Sobi Site 106 Suita Osaka Japan 565-0871
    16 Sobi Site 104 Hachiōji-shi Tokyo Japan 192-0032
    17 Sobi Site 103 Bunkyō-Ku Toyko Japan 113-8603
    18 Sobi Site 102 Chuo-shi Yamanashi Japan 409-3898
    19 Sobi Site 112 Kōfu Yamanashi Japan 400-8506

    Sponsors and Collaborators

    • Sobi, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sobi, Inc.
    ClinicalTrials.gov Identifier:
    NCT05369208
    Other Study ID Numbers:
    • AVA-ITP-307
    First Posted:
    May 11, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Sobi, Inc.
    ITP
    Additional relevant MeSH terms:
    Thrombocytopenia
    Purpura, Thrombocytopenic, Idiopathic

    Study Results

    No Results Posted as of Jul 15, 2022