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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05369208
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Sobi, Inc.

Study Description
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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
Immune Thrombocytopenia 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 15, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Doptelet


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative Number of Weeks of Platelet Response [ Time Frame: 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 [ Time Frame: Day 8 ]
    Proportion of subjects with a platelet response ≥50×10^9/L at Day 8 in the absence of rescue therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05369208


Contacts
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Contact: Sobi Clinical 781-786-7370 NAClinical@Sobi.com

Locations
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Sponsors and Collaborators
Sobi, Inc.
More Information
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Responsible Party: Sobi, Inc.
ClinicalTrials.gov Identifier: NCT05369208    
Other Study ID Numbers: AVA-ITP-307
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023

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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:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
 Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations