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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2004-000172-13-GB |
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Date of registration:
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11/02/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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) - Not available
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Scientific title:
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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) - Not available |
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Date of first enrolment:
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20/08/2008 |
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Target sample size:
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350 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000172-13 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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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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Germany
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Italy
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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:
1) Subjects must have previously completed an AMG 531 ITP study
2) Before any study specific procedure, the appropriate written informed consent (and assent, if applicable) was obtained.
Are the trial subjects under 18? yes
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:
1) Subject has any bone marrow stem cell disorders or new active malignancies diagnosed since enrolment in the previous AMG 531 ITP study.
2) Subject received any alkylating agents within 4 weeks before the Screening visit or anticipated use during the time of the proposed study
3) Subject is currently enrolled in or has not yet completed at least 4 weeks since ending other investigational device or drug trial(s) (other than the previous AMG 531 ITP study), or subject is receiving other investigational agent(s) other than AMG 531
4) Subject of child-bearing potential is evidently pregnant (eg, positive ß-hCG test) or is breast feeding
5) Subject is not using adequate contraceptive precautions
6) Subject will not be available for follow-up assessments
7) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative and/or is unable to comply with study 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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Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1
Level: LLT
Classification code 10021245
Term: Idiopathic thrombocytopenic purpura
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Intervention(s)
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Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
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Primary Outcome(s)
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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 Objective: 1) To evaluate the long- term platelet response to AMG 531
2) To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531
3) To evaluate changes in Patient Reported Outcomes ( PRO) due to the use of AMG 531
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Main Objective: To determine the safety of AMG 531 as a long- term treatment in thrombocytopenic subjects with ITP.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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