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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2007-000638-37-ES |
Date of registration:
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17/10/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).
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?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)?
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Scientific title:
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An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).
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?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)? |
Date of first enrolment:
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17/12/2008 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000638-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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Ireland
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion 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 - Subjects platelet count is ≤ 30 x10^9/L 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Exclusion Criteria - Subject has a history of hematological malignancy, myeloproliferative disorder, 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 subjects ability to comply with the protocol procedures
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Immune (Idiopathic) Thrombocytopenic Purpura.
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Púrpura Trombocitopénica Inmune (Idiopática) MedDRA version: 9.1
Level: LLT
Classification code 10021245
Term: Idiopathic thrombocytopenic purpura
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Intervention(s)
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Product Name: Romiplostim Product Code: AMG 531 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Romiplostim Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 600-
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Primary Outcome(s)
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Secondary Objective: This study will also evaluate hematological responses to Romiplostim.
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Main Objective: The primary objective of this study is to evaluate the safety of romiplostim in adult thrombocytopenic subjects with ITP.
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Primary end point(s): The primary endpoint is the incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation.
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Secondary ID(s)
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2007-000638-37-NL
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20040209
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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