Back to resultsAn Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Primary Purpose
Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenic Purpura
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Romiplostim
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring Platelet, AMG 531, Thrombopoietin, blood disorder, bleeding disorder, immune thrombocytopenic purpura, idiopathic thrombocytopenic purpura, immune (idiopathic) thrombocytopenic purpura, TPO, thrombopoietic protein
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years of age
- Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
- If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
- Subject has received at least 1 prior therapy for ITP
- Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
- Subject (or legally-acceptable representative) is willing and able to provide written informed consent
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
- 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
- Investigator has concerns regarding the subject's ability to comply with the protocol procedures
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Romiplostim
Outcomes
Primary Outcome Measures
Adverse Events
One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
Secondary Outcome Measures
Platelet Response (Definition 1)
Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L
Platelet Response (Definition 2)
Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00508820
Brief Title
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Official Title
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2005 (Actual)
Primary Completion Date
January 1, 2011 (Actual)
Study Completion Date
March 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenic Purpura
Keywords
Platelet, AMG 531, Thrombopoietin, blood disorder, bleeding disorder, immune thrombocytopenic purpura, idiopathic thrombocytopenic purpura, immune (idiopathic) thrombocytopenic purpura, TPO, thrombopoietic protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
407 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Romiplostim
Intervention Type
Biological
Intervention Name(s)
Romiplostim
Intervention Description
Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
Primary Outcome Measure Information:
Title
Adverse Events
Description
One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
Time Frame
Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.
Secondary Outcome Measure Information:
Title
Platelet Response (Definition 1)
Description
Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L
Time Frame
Duration of treatment (up to 201 weeks)
Title
Platelet Response (Definition 2)
Description
Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)
Time Frame
Duration of treatment (up to 201 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years of age
Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
Subject has received at least 1 prior therapy for ITP
Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
Subject (or legally-acceptable representative) is willing and able to provide written informed consent
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
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
Investigator has concerns regarding the subject's ability to comply with the protocol procedures
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
26066765
Citation
Janssens A, Tarantino M, Bird RJ, Mazzucconi MG, Boccia RV, Fernandez MF, Kozak T, Steurer M, Boekhorst Pt, Dillingham K, Kreuzbauer G, Woodard P. Romiplostim Treatment in Adults with Immune Thrombocytopenia of Varying Duration and Severity. Acta Haematol. 2015;134(4):215-28. doi: 10.1159/000381657.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
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