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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508820
First Posted: July 30, 2007
Last Update Posted: February 9, 2017
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.
Information provided by (Responsible Party):
Amgen
  Purpose
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 Intervention Phase
Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenic Purpura Biological: Romiplostim Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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:
  • 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

  • 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)


Enrollment: 407
Study Start Date: February 2005
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00508820     History of Changes
Other Study ID Numbers: 20040209
First Submitted: July 26, 2007
First Posted: July 30, 2007
Results First Submitted: January 11, 2012
Results First Posted: February 13, 2012
Last Update Posted: February 9, 2017
Last Verified: February 2017

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:
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases