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An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00508820
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : February 13, 2012
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenic Purpura Biological: Romiplostim Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Actual Study Start Date : February 1, 2005
Actual Primary Completion Date : January 1, 2011
Actual Study Completion Date : March 1, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Romiplostim
 Biological: Romiplostim
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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. ]
    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 :
  1. Platelet Response (Definition 1) [ Time Frame: Duration of treatment (up to 201 weeks) ]
    Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L

  2. Platelet Response (Definition 2) [ Time Frame: Duration of treatment (up to 201 weeks) ]
    Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508820


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00508820    
Other Study ID Numbers: 20040209
First Posted: July 30, 2007    Key Record Dates
Results First Posted: February 13, 2012
Last Update Posted: May 9, 2019
Last Verified: May 2019
Keywords provided by Amgen:
Platelet
AMG 531
Thrombopoietin
blood disorder
bleeding disorder
 immune thrombocytopenic purpura
idiopathic thrombocytopenic purpura
immune (idiopathic) thrombocytopenic purpura
TPO
thrombopoietic protein
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
 Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases