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Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (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: NCT00116688
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : April 6, 2011
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The purpose of this study is to determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to evaluate changes in patient reported outcomes due to the use of romiplostim. Participants must have previously completed a romiplostim ITP study.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Study Start Date : August 2004
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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: Romiplostim
Romiplostim weekly subcutaneous dosing based on screening weight and platelet count. Starting dose of 1 µg/kg up to a maximum dose of 10 µg/kg.
 Biological: Romiplostim
Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
Other Names:
  • AMG 531
  • Nplate


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Duration of treatment plus 8 weeks (up to 285 weeks) ]
    Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.


Secondary Outcome Measures :
  1. Number of Participants With a Platelet Response [ Time Frame: Duration of treatment (up to 277 weeks) ]
    Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.

  2. Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies [ Time Frame: Duration of treatment (up to 277 weeks) ]
    The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.

  3. Change From Baseline in ITP Patient Assessment Questionnaire [ Time Frame: Baseline to Week 48 ]
    The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women's Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.

  4. Change From Baseline in Short Form 36 (SF-36) [ Time Frame: Baseline to Week 48 ]
    The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.

  5. Change From Baseline in Euroqol-5D (EQ-5D) Index Score [ Time Frame: Baseline to Week 48 ]
    The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.

  6. Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS) [ Time Frame: Baseline to Week 48 ]
    The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent's self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.

  7. Patient Global Assessment [ Time Frame: Week 1 and Week 48 ]
    The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have previously completed a romiplostim ITP study
  • Platelet count ≤ 50 x 10 ^9/L
  • Written informed consent

Exclusion Criteria:

  • Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous romiplostim ITP study
  • Received any alkylating agents within 4 weeks before screening visit or anticipated use during the time of the proposed study
  • Currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving other investigational agent(s) other than romiplostim
  • Not using adequate contraceptive precautions
  • Not available for follow-up assessments
  • Has any kind of disorder that compromises the ability of the participant to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study 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): NCT00116688


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

Publications:
Terrell D, George J, Bussel J, Lyons R, Pullarkat V, Redner R, Nie, Selleslag D, Nie K, Woodard P.Home administration of romiplostim by patients with chronic immune thrombocytopenia (ITP).Journal-001500;
Terrell D, George J, Bussel J, Lyons R, Pullarkat V, Redner R, Nie, Selleslag D, Nie K, Woodard P.Home administration of romiplostim by patients with chronic immune thrombocytopenia (ITP).Journal-001752;

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00116688    
Other Study ID Numbers: 20030213
First Posted: July 1, 2005    Key Record Dates
Results First Posted: April 6, 2011
Last Update Posted: December 18, 2013
Last Verified: November 2013
Keywords provided by Amgen:
Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenic
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