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Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Primary Purpose

Thrombocytopenic Purpura

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Romiplostim
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenic Purpura focused on measuring Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, ITP, Thrombocytopenia

Eligibility Criteria

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

Inclusion Criteria: Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP 2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy) Ability to give informed consent Exclusion Criteria: Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Romiplostim

    Arm Description

    Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events
    Number of Participants With Positive Anti-Romiplostim Antibodies
    The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.

    Secondary Outcome Measures

    Number of Participants Who Achieved a Targeted Therapeutic Platelet Response
    Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline
    Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L
    Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L
    Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Change From Baseline to Peak Platelet Level
    Platelet count data after the use of rescue medication were not included.
    Time to Peak Platelet Count
    Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included.
    Duration Within the Targeted Therapeutic Range
    Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included.

    Full Information

    First Posted
    June 30, 2005
    Last Updated
    June 22, 2023
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00117143
    Brief Title
    Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
    Official Title
    An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2, 2002 (Actual)
    Primary Completion Date
    July 19, 2004 (Actual)
    Study Completion Date
    July 19, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Romiplostim
    Arm Type
    Experimental
    Arm Description
    Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.
    Intervention Type
    Drug
    Intervention Name(s)
    Romiplostim
    Other Intervention Name(s)
    AMG 531, NPLATE
    Intervention Description
    Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events
    Time Frame
    From first dose through 8 weeks after last dose of study drug (11 weeks)
    Title
    Number of Participants With Positive Anti-Romiplostim Antibodies
    Description
    The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.
    Time Frame
    Days 29 and 78
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Achieved a Targeted Therapeutic Platelet Response
    Description
    Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Time Frame
    Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)
    Title
    Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline
    Description
    Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Time Frame
    Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)
    Title
    Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L
    Description
    Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Time Frame
    After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)
    Title
    Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L
    Description
    Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
    Time Frame
    After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)
    Title
    Change From Baseline to Peak Platelet Level
    Description
    Platelet count data after the use of rescue medication were not included.
    Time Frame
    Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)
    Title
    Time to Peak Platelet Count
    Description
    Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included.
    Time Frame
    From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78
    Title
    Duration Within the Targeted Therapeutic Range
    Description
    Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included.
    Time Frame
    From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP 2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy) Ability to give informed consent Exclusion Criteria: Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28411254
    Citation
    Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
    Results Reference
    background
    PubMed Identifier
    17061981
    Citation
    Newland A, Caulier MT, Kappers-Klunne M, Schipperus MR, Lefrere F, Zwaginga JJ, Christal J, Chen CF, Nichol JL. An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. Br J Haematol. 2006 Nov;135(4):547-53. doi: 10.1111/j.1365-2141.2006.06339.x.
    Results Reference
    background
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://www.nplate.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

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