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

Primary Purpose

Immune Thrombocytopenia

Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Avatrombopag Oral Tablet
Sponsored by
Sobi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sobi Site 105
  • Sobi Site 110
  • Sobi Site 118
  • Sobi Site 116
  • Sobi Site 117
  • Sobi Site 114
  • Sobi Site 115
  • Sobi Site 109
  • Sobi Site 108
  • Sobi Site 113
  • Sobi Site 101
  • Sobi Site 111
  • Sobi Site 119
  • Sobi Site 107
  • Sobi Site 106
  • Sobi Site 104
  • Sobi Site 103
  • Sobi Site 102
  • Sobi Site 112

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Avatrombopag

Arm Description

Avatrombopag 20 mg oral tablet

Outcomes

Primary Outcome Measures

Cumulative Number of Weeks of Platelet Response
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

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

Full Information

First Posted
April 21, 2022
Last Updated
August 15, 2023
Sponsor
Sobi, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05369208
Brief Title
Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
January 18, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sobi, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
ITP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avatrombopag
Arm Type
Other
Arm Description
Avatrombopag 20 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Avatrombopag Oral Tablet
Other Intervention Name(s)
Doptelet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative Number of Weeks of Platelet Response
Description
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.
Time Frame
26 weeks of active treatment
Secondary Outcome Measure Information:
Title
Response Rate at Day 8
Description
Proportion of subjects with a platelet response ≥50×10^9/L at Day 8 in the absence of rescue therapy
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sobi Site 105
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Sobi Site 110
City
Toon City
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Sobi Site 118
City
Iizuka-shi
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Sobi Site 116
City
Kitakyushu City
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Sobi Site 117
City
Kurume City
State/Province
Fukuoka
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Sobi Site 114
City
Gifu City
State/Province
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Sobi Site 115
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-2121
Country
Japan
Facility Name
Sobi Site 109
City
Hiroshima City
State/Province
Hiroshima
ZIP/Postal Code
730-0052
Country
Japan
Facility Name
Sobi Site 108
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Sobi Site 113
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Sobi Site 101
City
Shiwa-gun
State/Province
Iwata
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Sobi Site 111
City
Fujisawa City
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Sobi Site 119
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Sobi Site 107
City
Hirakata City
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Sobi Site 106
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Sobi Site 104
City
Hachiōji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Sobi Site 103
City
Bunkyō-Ku
State/Province
Toyko
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Sobi Site 102
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Sobi Site 112
City
Kōfu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan

12. IPD Sharing Statement

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

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