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Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura

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ClinicalTrials.gov Identifier: NCT03830749
Recruitment Status : Suspended (Due to the COVID-19 pandemic)
First Posted : February 5, 2019
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Humanity & Health Medical Group Limited

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date March 17, 2022
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2019)
The prolonged response rate [ Time Frame: 6 months after completion of therapy ]
Defined as proportion of patients with platelet counts > 50,000/μl at 6 months after completion of therapy and free of ITP rescue therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2019)
  • Time to relapse [ Time Frame: 6 months after completion of therapy ]
    Defined as the interval from completion of 3 months treatment to platelet count<30,000/ul and restarting of ITP therapy including but not limited to platelet transfusion, IVIG, corticosteroids, immunosuppressive drugs, rituximab
  • Early response rate [ Time Frame: 6 months after completion of therapy ]
    Defined as proportion of patients requiring less than 3 courses of pulsed dexamethasone to maintain platelet counts > 150,000/ul
  • Health related quality of life [ Time Frame: 6 months after completion of therapy ]
    Assessed by SV36 HRQoL questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura
Official Title  ICMJE A Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP)
Brief Summary Current first line treatments for immune thrombocytopenia (ITP) usually have transient effects and prolonged platelet response rate off therapy remains low. The aim is to evaluate whether a 12-week course of eltrombopag plus pulsed dexamethasone as first line therapy can increase the proportion of patients with prolonged response. Diagnosis of ITP is established according to the American Society of Hematology guidelines. Eligible ITP subjects have platelet counts <30×109/L or counts <50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above). Subjects must have no prior ITP treatment except platelet transfusions. Treatment consists of eltrombopag 25-75 mg daily according to platelet response for 12 weeks plus pulsed dexamethasone, 40 mg daily for 4 consecutive days every 4 weeks for 1-3 courses. The primary endpoint is prolonged response rate which was defined as the proportion of enrolled subjects maintaining platelet counts >50×109/L for more than 6 months without any ITP therapy after completion of 12-week therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia
Intervention  ICMJE Drug: Eltrombopag
Eltrombopag Oral Tablet 25-75 mg daily for 12 weeks plus pulsed dexamethasone
Study Arms  ICMJE Experimental: Single Arm
Eltrombopag Oral Tablet 25-75 mg daily for 12 weeks plus pulsed dexamethasone
Intervention: Drug: Eltrombopag
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 3, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has signed and dated a written informed consent.
  2. Adults (≥18 years) diagnosed with ITP according to the American Society for Hematology/British Committee for Standards in Haematology (ASH/BCSH) Guidelines. In addition, the peripheral blood smear should support the diagnosis of ITP with no evidence of other disease causative of thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical examination should be normal or at least not show signs suggestive of any disease likely to be associated with thrombocytopenia.
  3. No prior ITP treatment except platelet transfusions
  4. Subject has no intercurrent medical event, including evidence of any thrombosis.
  5. Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT), no history of hypercoagulable state.
  6. The following clinical chemistries must be within the normal reference range:

    creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase.

  7. Subject is practicing an acceptable method of contraception (documented in chart).
  8. Subject is able to understand and comply with protocol requirements and instructions.

Exclusion Criteria:

  1. Any clinically relevant abnormality, other than ITP, identified on the screening examination, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another diagnosis.
  2. History of active malignancy or on cancer therapy. Patients with a history of malignancy in complete remission for longer than 5 years are eligible
  3. History of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism).
  4. ≥ two of the following risk factors: Factor V Leiden, hormone replacement therapy, systemic contraception containing estrogen, smoking, diabetes, hypercholesterolemia, medications for hypertension or cancer.
  5. Pre-existing cardiac disease (including congestive heart failure, and arrhythmia requiring treatment), or clinically significant findings on resting 12-lead ECG at screening.
  6. Female subjects who are nursing or pregnant (positive serum or urine β-human chorionic gonadotrophin (β-hCG) pregnancy test) at screening or pre-dose on Day 1.
  7. History of alcohol/drug abuse.
  8. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03830749
Other Study ID Numbers  ICMJE HHRC_ITP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Humanity & Health Medical Group Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Humanity & Health Medical Group Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory Cheng, PhD, MD Humanity & Health Research Centre
PRS Account Humanity & Health Medical Group Limited
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP