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AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy

Primary Purpose

Thrombocytopenia, Idiopathic Thrombocytopenic Purpura

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AMG 531
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring immune (idiopathic) thrombocytopenic purpura, pre-splenectomy, ITP, Thrombopenia

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F) Have completed as least 1 prior treatment for ITP (e.g., prednisone) Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be: *less than 30 x 10^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10^9/L *less than 50 x 10^9/L for those subjects receiving a constant dose schedule of corticosteroids, azathioprine or danazol with no count greater than 55 x 10^9/L A serum creatinine concentration less than or equal to 2 mg/dl (less than or equal to 176.8 µmol/L) Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range Hemoglobin greater than 11.0 g/dL Written informed consent (see Section 12.1) Exclusion Criteria: Have had a Splenectomy for any reason Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study) Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization Documented diagnosis of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) in the past year History of venous thrombosis (i.e., deep vein thrombosis, pulmonary embolism) including those subjects who are on ant-coagulation therapy Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [NYHA greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia) Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker; using oral contraceptives; on estrogen therapy; known positive for anti-phospholipid antibodies; hypertriglyceridemia; hypercholesteremia (greater than 240 mg/dL); treatment for hypertension Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus Currently receiving any treatment for ITP except corticosteroids, azathioprine or danazol administered at a constant dose and schedule IV Ig or anti-D Ig within 2 weeks before the screening visit Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531 or related platelet product Received any aklylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period - Less than 8 weeks since major surgery Pregnant or breast feeding Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator Known hypersensitivity to any recombinant E coli-derived product Concerns for subject's compliance with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AMG 531

    Placebo

    Arm Description

    Active investigational product

    Outcomes

    Primary Outcome Measures

    To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters

    Secondary Outcome Measures

    To evaluate the overall safety of AMG 531
    To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531
    To evaluate changes in Patient Reported Outcomes (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531

    Full Information

    First Posted
    January 27, 2005
    Last Updated
    November 4, 2022
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00102336
    Brief Title
    AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
    Official Title
    A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 7, 2005 (Actual)
    Primary Completion Date
    December 1, 2006 (Actual)
    Study Completion Date
    April 1, 2007 (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 evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
    Keywords
    immune (idiopathic) thrombocytopenic purpura, pre-splenectomy, ITP, Thrombopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMG 531
    Arm Type
    Experimental
    Arm Description
    Active investigational product
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    AMG 531
    Intervention Description
    Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.
    Primary Outcome Measure Information:
    Title
    To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters
    Time Frame
    Last 8 weeks of treatments
    Secondary Outcome Measure Information:
    Title
    To evaluate the overall safety of AMG 531
    Time Frame
    Entire duration of the study including the follow up period
    Title
    To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531
    Time Frame
    Entire duration of the study
    Title
    To evaluate changes in Patient Reported Outcomes (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531
    Time Frame
    Entire duration of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F) Have completed as least 1 prior treatment for ITP (e.g., prednisone) Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be: *less than 30 x 10^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10^9/L *less than 50 x 10^9/L for those subjects receiving a constant dose schedule of corticosteroids, azathioprine or danazol with no count greater than 55 x 10^9/L A serum creatinine concentration less than or equal to 2 mg/dl (less than or equal to 176.8 µmol/L) Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range Hemoglobin greater than 11.0 g/dL Written informed consent (see Section 12.1) Exclusion Criteria: Have had a Splenectomy for any reason Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study) Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization Documented diagnosis of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) in the past year History of venous thrombosis (i.e., deep vein thrombosis, pulmonary embolism) including those subjects who are on ant-coagulation therapy Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [NYHA greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia) Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker; using oral contraceptives; on estrogen therapy; known positive for anti-phospholipid antibodies; hypertriglyceridemia; hypercholesteremia (greater than 240 mg/dL); treatment for hypertension Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus Currently receiving any treatment for ITP except corticosteroids, azathioprine or danazol administered at a constant dose and schedule IV Ig or anti-D Ig within 2 weeks before the screening visit Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531 or related platelet product Received any aklylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period - Less than 8 weeks since major surgery Pregnant or breast feeding Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator Known hypersensitivity to any recombinant E coli-derived product Concerns for subject's compliance with the protocol
    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
    30793285
    Citation
    Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.
    Results Reference
    background
    PubMed Identifier
    32129511
    Citation
    Kuter DJ, Arnold DM, Rodeghiero F, Janssens A, Selleslag D, Bird R, Newland A, Mayer J, Wang K, Olie R. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. Am J Hematol. 2020 Jun;95(6):643-651. doi: 10.1002/ajh.25776. Epub 2020 Mar 21.
    Results Reference
    background
    PubMed Identifier
    22494019
    Citation
    Weitz I, Sanz MA, Henry D, Schipperus M, Godeau B, Northridge K, Gleeson M, Danese M, Deuson R. A novel approach to the evaluation of bleeding-related episodes in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 May;28(5):789-96. doi: 10.1185/03007995.2012.684046. Epub 2012 Apr 25.
    Results Reference
    derived
    PubMed Identifier
    19671919
    Citation
    Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. doi: 10.1182/blood-2009-05-224766. Epub 2009 Aug 11.
    Results Reference
    derived
    PubMed Identifier
    18242413
    Citation
    Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH Jr, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrere F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. doi: 10.1016/S0140-6736(08)60203-2.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_46_AMP-2_20030212.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.nplate.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy

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