Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Conditions
Interventions
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: mg/ml milligram(s)/millil
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety of AMG 531 as a long- term treatment in thrombocytopenic subjects with ITP.; 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 ;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 | — |
Countries
Austria, Belgium, Czech Republic, Germany, Italy, United Kingdom
Outcome results
None listed