Status:
COMPLETED
Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology
Lead Sponsor:
Amgen
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Brief Summary
This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and 20030212) and an open-label extension study (20030213) and compared pretreatment and posttreatment bone marr...
Detailed Description
This study is to be performed in conjunction with the phase 3 treatment studies (20030105 and 20030212) and with the open label extension study (20030213). Subjects who are screening for participatio...
Eligibility Criteria
Inclusion
- Subjects must be enrolled in AMG 531 protocol 20030105 or 20030212
- Subject must have had a bone marrow biopsy within one year of enrollment (with available tissue block to send to a central pathology laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy and aspirate
- Written informed consent
Exclusion
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00861224
Start Date
August 1 2005
End Date
May 1 2007
Last Update
July 16 2010
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