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

• Conditions: Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP); MedDRA version: 8.1Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpura

• Registration Number: EUCTR2004-000172-13-BE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-27
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified