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Study Complete
Sponsor ID
20050123

Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology

Sponsor ID
20050123
Clinicaltrials.gov ID
NCT00861224
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 marrow samples for the purpose of studying morphologic changes.

Additional Study Details

Phase
N/A
Product
romiplostim
Type
Observational
Masking
N/A
Enrollment
10
Additional Study Details

Protocol Summary

Primary Outcome Measures

The changes from baseline in bone marrow morphology by subject

Timeframe: Entire duration of the study

Secondary Outcome Measures

The changes from baseline in bone marrow morphology by dose range

Timeframe: Entire duration of the study

The changes from baseline in bone marrow morphology by length of treatment with AMG 531

Timeframe: Entire duration of the study

The changes from baseline bone marrow morphology for splenectomized and non-splenectomized subjects

Timeframe: Entire duration of the study

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Aug 2005 - Oct 2006
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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 Criteria:
    - 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