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An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

Primary Purpose

Immune Thrombocytopenia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Romiplostim
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject has an ability to provide written informed consent prior to participating to the study
  2. Subject is male or female ≥ 18 years of age
  3. Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines.
  4. Subject received at least 1 prior therapy for ITP including corticosteroids, immunoglobulin, or splenectomy, but had an insufficient response to any of these treatment (PLT count should be < 30x109/L before romiplostim initiation.)
  5. If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period

Exclusion Criteria:

  1. Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
  2. Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product within 8 weeks
  3. Subject has a known hypersensitivity to any recombinant E coli-derived product
  4. Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
  5. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
  6. Subject is pregnant or breast feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Romiplostim

    Arm Description

    Patients receiving romiplostim due to ITP

    Outcomes

    Primary Outcome Measures

    Efficacy of biweekly romiplostim (platelet counts ≥ 30 x 10^9/L)
    To evaluate the proportion of patients who had platelet counts ≥ 30 x 109/L during 4 or more weeks with biweekly romiplostim

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2015
    Last Updated
    January 11, 2015
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02338414
    Brief Title
    An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP
    Official Title
    An Observational Study to Evaluate the Efficacy of Romiplostim Administered at Every Other Week in Adult Patients With Chronic Immune Thrombocytopenia (ITP) Who Attained Platelet Counts ≥ 50 x 109/L After Weekly Doses of Romiplostim
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    January 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the efficacy of romiplostim administered at every other week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive weeks after weekly doses of romiplostim.
    Detailed Description
    Regarding the determination of appropriate dose, it is well known that romiplostim resulted in dose-dependent increases in platelet counts, but required dose for raising platelet count is variable between individuals according to each patient's ability to eliminate serum romiplostim. Because of this variability, after administration of initial 1mcg/kg of romiplostim, dose adjustment is recommended based on the platelet response to given dose of romiplostim. However, the optimal dose interval of romiplostim has rarely been studied. In pivotal studies, romiplostim was administered on a weekly schedule, and based on these studies, one dose at every week is being widely used. In one study in which ITP patients received weekly subcutaneous doses of romiplostim at a range from 3 to 15mcg/kg, half life of romiplostim was estimated from 1 to 34 days, suggesting that lengthening the interval between doses more than a week can be potentially possible in some patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Romiplostim
    Arm Type
    Other
    Arm Description
    Patients receiving romiplostim due to ITP
    Intervention Type
    Drug
    Intervention Name(s)
    Romiplostim
    Other Intervention Name(s)
    Nplate
    Intervention Description
    Subcutaneous Romiplostim (weekly injection) -> if titrated with maintaining PLT count between 50-200 x 10^9/L -> Subcutaneous Romiplostim (biweekly injection)
    Primary Outcome Measure Information:
    Title
    Efficacy of biweekly romiplostim (platelet counts ≥ 30 x 10^9/L)
    Description
    To evaluate the proportion of patients who had platelet counts ≥ 30 x 109/L during 4 or more weeks with biweekly romiplostim
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject has an ability to provide written informed consent prior to participating to the study Subject is male or female ≥ 18 years of age Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines. Subject received at least 1 prior therapy for ITP including corticosteroids, immunoglobulin, or splenectomy, but had an insufficient response to any of these treatment (PLT count should be < 30x109/L before romiplostim initiation.) If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period Exclusion Criteria: Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product within 8 weeks Subject has a known hypersensitivity to any recombinant E coli-derived product Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator Subject is pregnant or breast feeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Ho Jang, M.D. Ph.D.
    Phone
    +82-2-3410-0918
    Email
    smcjunhojang@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jong Wook Lee, M.D.
    Organizational Affiliation
    Seoul St. Mary's Hospital, The Catholic University of Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

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